MedtechSourcebook

Precision Edge Surgical Products Co LLC

Contract manufacturer · Boyne City, MI

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

FDA registration
3013820441 (openFDA record; or search FDA's registration database)
FEI number
3013820441
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator
Precision Edge Surgical Products Company (FDA owner/operator no. 10042577)
Registered address
1448 Lexamar Drive, Boyne City, MI 49712
Contract listings
16 device listings, 10 product codes, first listed Dec 10, 2012
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 codeDevice (FDA name)ClassCategoryRoleFirst listed
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingAug 23, 2018
HSBRod, Fixation, Intramedullary And AccessoriesClass IIOrthopedicContract manufacturingOct 18, 2021
HTOReamerClass IOrthopedicContract manufacturingDec 10, 2012
HTWBit, DrillClass IOrthopedicContract manufacturingDec 10, 2012
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingJul 21, 2016
HWWCountersinkClass IOrthopedicContract manufacturingMay 20, 2020
HWXTap, BoneClass IOrthopedicContract manufacturingApr 17, 2017
HXXScrewdriverClass IOrthopedicContract manufacturingNov 8, 2018
JDRStaple, Fixation, BoneClass IIOrthopedicContract manufacturingSep 14, 2023
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingJan 14, 2013

Other contract facilities of Precision Edge Surgical Products Company