Identity
- Trade Name
- Novation FDA UDI
- Generic Name
- Press-fit femoral stem prosthesis FDA UDI
- Model / Reference
- 160-10-15 FDA UDI
Identifiers
- Catalog Number
- 160-10-15 FDA UDI
- Primary DI / UDI-DI
- 10885862031945 FDA UDI
- 510(k) Number
- K042842 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDILWJ FDA UDIJDI FDA UDI
- GMDN Term
- Press-fit femoral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 FDA UDI888.3350 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Press-fit femoral stem prosthesis
Novation by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Press-fit femoral stem prosthesis.
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- 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
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K042842 also covers:
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — 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 33edd049-ce65-4272-8949-7c0f825d2f91 35 fields · synced May 30, 2026