Identity
- Trade Name
- Wagner Cone Prosthesis® FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, modular FDA UDI
- Device Name
- Wagner Cone Prosthesis 125°, Ø 16 FDA UDI
- Model / Reference
- 01.00561.216 FDA UDI
- Description
- Wagner Cone Prosthesis 125°, Ø 16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024282100 FDA UDI
- FDA Product Code
- KWZ FDA UDILPH FDA UDIJDI FDA UDILZO FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3310 FDA UDI888.3358 FDA UDI888.3350 FDA UDI888.3353 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Angle — 125 degree FDA UDIOuter Diameter — 16 Millimeter FDA UDI
Category: Press-fit hip femur prosthesis, modular
Wagner Cone Prosthesis® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, modular.
- Perfecta — MicroPort Orthopedics Inc. · Class III
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
- Profemur — MicroPort Orthopedics Inc. · Class III
- Profemur — MicroPort Orthopedics Inc. · Class III
- UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Profemur — MicroPort Orthopedics Inc. · Class II
- Perfecta — MicroPort Orthopedics Inc. · Class III
- Profemur — MicroPort Orthopedics Inc. · Class III
Cleared under the same submission
K032380 also covers:
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
K113556 also covers:
- Impactor — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
- Wagner Cone Prosthesis® — Zimmer, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 41b45101-8774-4dc5-9b22-84f1d37bdada 36 fields · synced May 31, 2026