Treace Medical, Inc.
Walker, MI, US
Treace Medical, Inc. appears in FDA device records in Walker, MI. FDA records list 80 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 80
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 80FDA records hold 80 510(k) clearances for Treace Medical, Inc. between 1982 and 1989. The busiest year on record is 1982, with 23. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 23 |
| 1983 | 19 |
| 1984 | 9 |
| 1985 | 2 |
| 1986 | 10 |
| 1987 | 14 |
| 1988 | 2 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K883727 | BUCKET PROSTHESIS PORP | ETB | Substantially Equivalent | |
| K882349 | MALLET, SURGICAL | HXL | Substantially Equivalent | |
| K874779 | BIPOLATOR 50 | GEI | Substantially Equivalent | |
| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | ERL | Substantially Equivalent | |
| K872000 | EYE GARD | HOY | Substantially Equivalent | |
| K870765 | CANNULATED INSTRUMENT CLEANERS | EKW | Substantially Equivalent | |
| K871706 | OPTHA PREP | HMT | Substantially Equivalent | |
| K870759 | CLEANING SOLUTION, CATALOG NO. 8203 | LRJ | Substantially Equivalent | |
| K870766 | PROSTHESIS WIRE | ETB | Substantially Equivalent | |
| K870764 | SCHUKNECHT WIRE CUTTING SCISSORS | Substantially Equivalent | ||
| K870763 | SUPER SCISSORS | Substantially Equivalent | ||
| K870760 | BUR BRUSH | Substantially Equivalent | ||
| K870762 | EAR APPLICATOR, CATALOG NO. 2229 | KXF | Substantially Equivalent | |
| K870757 | OTOLOGICAL METRIC SCALE/GAUGE | Substantially Equivalent | ||
| K870758 | SMALL MASTOID RETRACTOR | KAL | Substantially Equivalent | |
| K870761 | EAR LOOP | JYQ | Substantially Equivalent | |
| K870756 | VEIN GRAFT EAR SCISSORS | JZB | Substantially Equivalent | |
| K863382 | CANNON NASAL SPLINT | EPP | Substantially Equivalent | |
| K863413 | BIPOLFORCEPS | GEI | Substantially Equivalent | |
| K863412 | BIPOL CABLE | GEI | Substantially Equivalent | |
| K863414 | MICROBIPOLATOR | GEI | Substantially Equivalent | |
| K862807 | TREACE DRILL SYSTEM | ERL | Substantially Equivalent | |
| K862584 | OSTEOTOMY DRAINAGE TUBE | GBS | Substantially Equivalent | |
| K862582 | TREACE MEDICAL MICRO INSTRUMENT WIPE | Substantially Equivalent | ||
| K862583 | LITE TOUCH GELFOAM INSERT | Substantially Equivalent | ||
| K861914 | TREACE MEDICAL FOAM INSTRUMENT PAD | Substantially Equivalent | ||
| K861915 | SURGICAL HEAD SUPPORT | CCX | Substantially Equivalent | |
| K844378 | OIL, MINERAL | Substantially Equivalent | ||
| K844377 | SILICONE | Substantially Equivalent | ||
| K844379 | STONE, INSTRUMENT HONING | Substantially Equivalent | ||
| K834094 | AUSTIN ENDOLYMPH DISPERSMENT SHUNT | ESZ | Substantially Equivalent | |
| K841357 | MICRO FLUID APPLICATOR | JZF | Substantially Equivalent | |
| K841359 | FENESTRA HOOK | IYL | Substantially Equivalent | |
| K841356 | ELEVATOR | KAD | Substantially Equivalent | |
| K841354 | CURETTE | JYG | Substantially Equivalent | |
| K841353 | CAUSSE SPONGE BOAT | ETB | Substantially Equivalent | |
| K841355 | RIGHT ANGLED PICK | JYT | Substantially Equivalent | |
| K834093 | PERFORATOR BUR | Substantially Equivalent | ||
| K823910 | DONALDSON VENT TUBE | ETD | Substantially Equivalent | |
| K823919 | TOTAL OSSICULAR REPLACEMENT | ETA | Substantially Equivalent | |
| K823918 | AUSTIN MODIFIED PARTIAL OSSICULAR RE- | ETA | Substantially Equivalent | |
| K823917 | PARTIAL OSSICULAR REPLACEMENT | ETA | Substantially Equivalent | |
| K823912 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | ETA | Substantially Equivalent | |
| K831589 | VENT TUBE FORCEPS | EQH | Substantially Equivalent | |
| K831590 | T-TUBE INSERTER | EQH | Substantially Equivalent | |
| K831588 | INSTRUMENT GUARD CAPSULE | KCT | Substantially Equivalent | |
| K830584 | SOILEAU TYTAN BOBBIN VENT TUBE | ETD | Substantially Equivalent | |
| K823909 | T-TUBE VENT TUBE | ETD | Substantially Equivalent | |
| K830085 | COLLAR BUTTON VENT TUBE | ETD | Substantially Equivalent | |
| K823908 | GROMMET VENT TUBE | ETD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- JXSBlock, Cutting, Ent, Sterile
- EKWBroach, Endodontic
- GBSCatheter, Ventricular, General & Plastic Surgery
- IYLCollimator, Dermatological, Therapeutic X-Ray
- JYGCurette, Ear
- LRJDisinfectant, Medical Devices
- HMTDrape, Patient, Ophthalmic
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- KADElevator, Ent
- EKBExplorer, Operative
- KAEForceps, Ent
- EJBHandle, Instrument, Dental
- JYMInserter, Myringotomy Tube
- JYOKnife, Ear
- JYQLoop, Wire
- HXLMallet
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic
- EPTMicroscope, Surgical
- FSOMicroscope, Surgical, General & Plastic Surgery
- KAIMirror, Ent
- JYTPick, Microsurgical Ear
- LBMPorous Polyethylene Ossicular Replacement
- JYWPress, Vein
- ETBProsthesis, Partial Ossicular Replacement
- ETAReplacement, Ossicular Prosthesis, Total
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene
- KALRetractor, Ent
- JZBScissors, Ear
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- EPPSplint, Nasal
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- CCXSupport, Patient Position
- FSMTray, Surgical, Instrument
- JZFTube, Ear Suction
- ESZTube, Shunt, Endolymphatic
- ETDTube, Tympanostomy
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain