Identity
- Trade Name
- TriFit TS Blade Stem FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- DOUBLE OFFSET IMPACTION HANDLE (RIGHT) FDA UDI
- Model / Reference
- 695.954 FDA UDI
- Description
- DOUBLE OFFSET IMPACTION HANDLE (RIGHT) FDA UDI
Identifiers
- Catalog Number
- 695.954 FDA UDI
- Primary DI / UDI-DI
- 05055343888353 FDA UDI
- 510(k) Number
- K121563 FDA UDI
- FDA Product Code
- KWL FDA UDIKWY FDA UDILZO FDA UDIMEH FDA UDI
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3390 FDA UDI888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant impactor, reusable
TriFit TS Blade Stem by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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Cleared under the same submission
K121563 also covers:
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
- TriFit TS Blade Stem — CORIN LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Corin Ltd
Sources (1)
- FDA UDI 0a84b416-becf-4b7e-97d5-5653a482c777 36 fields · synced May 30, 2026