Identity
- Trade Name
- H-Max Instrument Set FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- Trial Modular Neck #16 FDA UDI
- Model / Reference
- Trial Modular Neck FDA UDI
- Description
- Trial Modular Neck #16 FDA UDI
Identifiers
- Catalog Number
- 9042.50.160 FDA UDI
- Primary DI / UDI-DI
- 08033390065405 FDA UDI
- 510(k) Number
- K112091 FDA UDI
- FDA Product Code
- MEH FDA UDIJDI FDA UDI
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femoral stem prosthesis trial
H-Max Instrument Set by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112091 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 8ed79b77-d167-4750-8857-96f667d0c627 36 fields · synced May 31, 2026