SINGLE SOURCE MEDICAL LLC

Contract manufacturer · Churubusco, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2013Product codes first listed, by year (tallest: 21)2026

FDA registration: 3010386387 (openFDA record; or search FDA's registration database)
FEI number: 3010386387
Registered for: FDA registration year 2026
Establishment types: Manufacturer for export only; Contract manufacturer
Owner or operator: Single Source Medical LLC (FDA owner/operator no. 10043888)
Registered address: 4506 S State Road 9 57, Churubusco, IN 46723
Contract listings: 35 device listings, 46 product codes, first listed Apr 2, 2013
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
FZO	Chisel, Surgical, Manual	Class I	General and plastic surgery	Contract manufacturing	Apr 22, 2019
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Apr 5, 2013
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jun 6, 2021
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Oct 10, 2019
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Oct 10, 2019
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Oct 10, 2019
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Sep 10, 2019
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Aug 22, 2019
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Apr 5, 2013
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Apr 5, 2013
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Jun 6, 2021
HWM	Osteotome	Class I	General and plastic surgery	Contract manufacturing	Jun 6, 2021
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract manufacturing	Jun 6, 2021
HWT	Template	Class I	Orthopedic	Contract manufacturing	Apr 3, 2013
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Apr 5, 2013
HXG	Tamp	Class I	Orthopedic	Contract manufacturing	Nov 30, 2018
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jun 6, 2021
HYA	Forceps, Wire Holding	Class I	General and plastic surgery	Contract manufacturing	Sep 25, 2019
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class III	Orthopedic	Contract manufacturing	Apr 2, 2013
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Class II	Orthopedic	Contract manufacturing	Feb 22, 2019
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 11, 2019
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class III	Orthopedic	Contract manufacturing	Apr 2, 2013
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Sep 13, 2019
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Sep 13, 2019
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Apr 3, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Sep 13, 2019
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Aug 22, 2019
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Aug 22, 2019
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Feb 26, 2019
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract manufacturing	Apr 2, 2013
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Aug 22, 2019
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Aug 22, 2019
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Aug 22, 2019
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Jun 6, 2021
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Class II	Orthopedic	Contract manufacturing	Sep 13, 2019
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Class II	Orthopedic	Contract manufacturing	Aug 22, 2019
PGM	Growing Rod System	Class II	Orthopedic	Contract manufacturing	Apr 28, 2026
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	Sep 13, 2019