Identity
- Trade Name
- Novation FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- NOVATION A+, OSTEOTOME, BOX FDA UDI
- Model / Reference
- 167-00-03 FDA UDI
- Description
- NOVATION A+, OSTEOTOME, BOX FDA UDI
Identifiers
- Catalog Number
- 167-00-03 FDA UDI
- Primary DI / UDI-DI
- 10885862035998 FDA UDI
- 510(k) Number
- K080980 FDA UDI
- FDA Product Code
- MEH FDA UDI
- GMDN Term
- Orthopaedic osteotome 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
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: Orthopaedic osteotome
Novation by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome.
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- Hayden Medical — Hayden Medical Inc · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- Bone Tamp — SONTEC INSTRUMENTS, INC. · Class I
- Symmetry Lambotte — SYMMETRY SURGICAL INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- ORTHOMED — ORTHO-MED, INC. · Class I
Cleared under the same submission
K080980 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 248aab37-3bed-4e83-a6d9-926199c8ed47 35 fields · synced May 31, 2026