Contract manufacturerCriterion Tool & Die Inc DBA Criterion Precision Machining (Brookpark, OH)OhioGeneral and plastic surgeryOrthopedicClass IClass II
Criterion Tool & Die Inc DBA Criterion Precision Machining
Contract manufacturer · Brookpark, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1528668 (openFDA record; or search FDA's registration database)
- FEI number
- 1000136409
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- CRITERION TOOL & DIE INC (FDA owner/operator no. 9005596)
- Registered address
- Criterion Tool & Die Inc Dba Criterion Precision Machining, 5349 W 161st St, Brookpark, OH 44142
- Contract listings
- 10 device listings, 11 product codes, first listed Jan 22, 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 |
|---|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jan 22, 2013 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | May 15, 2017 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Jun 8, 2017 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| KCY | Tourniquet, Pneumatic | Class I | General and plastic surgery | Contract manufacturing | Jan 23, 2013 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | May 15, 2017 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Jun 8, 2017 |