Identity
- Trade Name
- H-MAX S Stem FDA UDI
- Generic Name
- Press-fit femoral stem prosthesis FDA UDI
- Device Name
- H-MAX S Stem - Standard - Taper 12/14 #10 H.140mm FDA UDI
- Model / Reference
- 4250.20.100 FDA UDI
- Description
- H-MAX S Stem - Standard - Taper 12/14 #10 H.140mm FDA UDI
Identifiers
- Catalog Number
- 4250.20.100 FDA UDI
- Primary DI / UDI-DI
- 08033390298896 FDA UDI
- 510(k) Number
- K160011 FDA UDI
- FDA Product Code
- KWY FDA UDIJDI FDA UDIMEH FDA UDI
- GMDN Term
- Press-fit femoral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3390 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: Press-fit femoral stem prosthesis
H-MAX S Stem by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit femoral stem prosthesis.
- Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II
- Novation — Exactech, Inc. · Class II
- Restoration — Howmedica Osteonics Corp. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class III
- Restoration — Howmedica Osteonics Corp. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
- BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Accolade — Howmedica Osteonics Corp. · Class II
Cleared under the same submission
K160011 also covers:
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Lateralizing — Limacorporate
- H-MAX S Standard — 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 29dacb14-7e06-4642-90f2-0e8c17cb6c07 36 fields · synced Jun 1, 2026