Identity
- Trade Name
- Acumatch M-Series FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, modular FDA UDI
- Model / Reference
- 150-01-05 FDA UDI
Identifiers
- Catalog Number
- 150-01-05 FDA UDI
- Primary DI / UDI-DI
- 10885862028013 FDA UDI
- 510(k) Number
- K010120 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Height — -5 Millimeter FDA UDI
Acumatch M-Series by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K010120 also covers:
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
- Exactech, Inc.
Sources (1)
- FDA UDI abdd969b-7e23-48bf-bd84-a65d1c4f3d0d 36 fields · synced Jun 1, 2026