Identity
- Trade Name
- AcuMatch FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Model / Reference
- 142-28-24 FDA UDI
Identifiers
- Catalog Number
- 142-28-24 FDA UDI
- Primary DI / UDI-DI
- 10885862538123 FDA UDI
- 510(k) Number
- K173583 FDA UDI
- FDA Product Code
- LZO FDA UDIMEH FDA UDIOQI FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AcuMatch by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K173583 also covers:
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
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 cdc51d57-b363-4713-815f-abd98ee1f3e6 36 fields · synced May 31, 2026