Identity
- Trade Name
- PTX GLENOID GUIDE S46/S (WOS) FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- 269893 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489698934 FDA UDI
- 510(k) Number
- K171789 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDIKWT FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Ptx Glenoid Guide S46/S (wos) by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171789 also covers:
- ARROW® — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® ANATOMICAL POROUS GLENOID — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® ANATOMICAL POROUS GLENOID — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® ANATOMICAL POROUS GLENOID — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® ANATOMICAL POROUS GLENOID — FOURNITURES HOSPITALIERES INDUSTRIE
- ARROW® ANATOMICAL POROUS GLENOID — FOURNITURES HOSPITALIERES INDUSTRIE
- Arrow Humeral broach Ø8 L170 — FOURNITURES HOSPITALIERES INDUSTRIE
- Baseplate positioner/impactor — FOURNITURES HOSPITALIERES INDUSTRIE
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
- Fournitures Hospitalieres Industrie
Sources (1)
- FDA UDI 09b7652d-2924-4475-9e75-531ae34f110c 33 fields · synced May 31, 2026