Identity
- Trade Name
- MANZA HEADS FDA UDI
- Generic Name
- Metallic femoral head prosthesis FDA UDI
- Device Name
- MANZA COCR HEAD, 40, XL OFFSET FDA UDI
- Model / Reference
- 103-00-041 FDA UDI
- Description
- MANZA COCR HEAD, 40, XL OFFSET FDA UDI
Identifiers
- Catalog Number
- 103-00-041 FDA UDI
- Primary DI / UDI-DI
- 00841176101302 FDA UDI
- 510(k) Number
- K121297 FDA UDI
- FDA Product Code
- MEH FDA UDILPH FDA UDI
- GMDN Term
- Metallic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3358 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
Category: Metallic femoral head prosthesis
Manza Heads by Stinson Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K121297 also covers:
- Nifty Fifty VENTO Cup — Amplitude
- SIGNATURE Head - BIOLOX Delta — Amplitude
- SIROCCO Stem — Amplitude
- SIROCCO Stem — Amplitude
- SIROCCO Stem — Amplitude
- STRATUS Stem — Amplitude
- VENTO Cup — Amplitude
- VENTO Cup — Amplitude
- VENTO XLPE Liner — Amplitude
- VENTO XLPE Liner — Amplitude
- OrthoMedFlex — ORTHOMEDFLEX LLC
- Paxeon Aria — PAXEON RECONSTRUCTION LLC
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
- Stinson Orthopedics Inc.
Sources (1)
- FDA UDI 5fb1b77a-55c1-4ced-8de4-f64f8c95f00b 35 fields · synced May 29, 2026