Identity
- Trade Name
- Mectacer Biolox Option Heads FDA UDI
- Generic Name
- Femoral head/stem prosthesis adaptor FDA UDI
- Device Name
- Sleeve Size XL FDA UDI
- Model / Reference
- 01.29.243A FDA UDI
- Description
- Sleeve Size XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030809408 FDA UDI
- 510(k) Number
- K131518 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Femoral head/stem prosthesis adaptor 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Femoral head/stem prosthesis adaptor
Mectacer Biolox Option Heads by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femoral head/stem prosthesis adaptor.
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
- Fusion Taper Sleeve +6mm — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Biolox — Howmedica Osteonics Corp. · Class II
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Solitude Unipolar — ORTHO DEVELOPMENT CORP. · Class II
- CONSERVE® — MicroPort Orthopedics Inc. · Class II
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K131518 also covers:
- Mectacer Biolox Option Heads — Medacta International
- Mectacer Biolox Option Heads — Medacta International
- Mectacer Biolox Option Heads — Medacta International
- Mectacer Biolox Option Heads — Medacta International
- Mectacer Biolox Option Heads — Medacta International
- Mectacer Biolox Option Heads — Medacta International
- Mectacer Biolox Option Heads — Medacta International
- Mectacer Biolox Option Heads — Medacta International
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
- Medacta International
Sources (1)
- FDA UDI 09636b33-5055-46b6-b114-a1396df12536 34 fields · synced May 30, 2026