Identity
- Trade Name
- Ceramic Femoral Head FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, one-piece FDA UDI
- Device Name
- Ceramic Femoral Head 32mm +3.5mm FDA UDI
- Model / Reference
- 32mm +3.5mm FDA UDI
- Description
- Ceramic Femoral Head 32mm +3.5mm FDA UDI
Identifiers
- Catalog Number
- WE-1-1011 FDA UDI
- Primary DI / UDI-DI
- B046WE110110 FDA UDI
- 510(k) Number
- K971721 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Press-fit hip femur prosthesis, one-piece
Ceramic Femoral Head by Signal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, one-piece.
- Masterloc Femoral Stems — Medacta International · Class II
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED · Class II
- AMIStem H Femoral Stems — Medacta International · Class II
- Quadra H femoral stems — Medacta International · Class II
- Amis K Long femoral stems — Medacta International · Class II
- Klassic Blade Femoral Stem, Porous, Size 1 — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- AMIStem-H Proximal Coating — Medacta International · Class II
- Trivicta — ORTHO DEVELOPMENT CORP. · Class II
Cleared under the same submission
K971721 also covers:
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
- Signal Medical Corp.
Sources (1)
- FDA UDI 08cf5c5f-dad7-42c3-8f87-de9a808626c7 36 fields · synced May 31, 2026