Identity
- Trade Name
- Novation FDA UDI
- Generic Name
- Press-fit femoral stem prosthesis FDA UDI
- Model / Reference
- 164-13-10 FDA UDI
Identifiers
- Catalog Number
- 164-13-10 FDA UDI
- Primary DI / UDI-DI
- 10885862202680 FDA UDI
- 510(k) Number
- K113320 FDA UDI
- FDA Product Code
- MEH FDA UDI
- GMDN Term
- Press-fit femoral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 140 Millimeter FDA UDI
Category: Press-fit femoral stem prosthesis
Novation by Exactech, Inc. — 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
- 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
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K113320 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exactech, Inc.
Sources (1)
- FDA UDI 516b371b-a8fe-44a3-823e-6e530a03a6a5 35 fields · synced Jun 8, 2026