Identity
- Trade Name
- MASTERSL FDA UDI
- Generic Name
- Coated femoral stem prosthesis, modular FDA UDI
- Device Name
- Master SL (Ti6Al4V + PoroTi) #1 FDA UDI
- Model / Reference
- Uncemented Stem FDA UDI
- Description
- Master SL (Ti6Al4V + PoroTi) #1 FDA UDI
Identifiers
- Catalog Number
- 3515.21.210 FDA UDI
- Primary DI / UDI-DI
- 08033390083430 FDA UDI
- 510(k) Number
- K140975 FDA UDI
- FDA Product Code
- LPH FDA UDIKWZ FDA UDIKWY FDA UDIJDI FDA UDILZO FDA UDI
- GMDN Term
- Coated femoral stem prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3310 FDA UDI888.3390 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
No
FDA UDI
Category: Coated femoral stem prosthesis, modular
Mastersl by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated femoral stem prosthesis, modular.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
- STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Alteon — Exactech, Inc. · Class II
- ANTHOLOGY — Smith & Nephew, Inc. · Class III
- TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
Cleared under the same submission
K140975 also covers:
- C2 REVISION Hip — Limacorporate
- Canal Chisel — Limacorporate
- Double offset Broach handle — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
- MASTER SL Stem — Limacorporate
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
- Limacorporate
Sources (1)
- FDA UDI da102ae0-c6ad-425e-809a-5900be6c0d5a 36 fields · synced Jun 8, 2026