Identity
- Trade Name
- Novation FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- 180-01-66 FDA UDI
Identifiers
- Catalog Number
- 180-01-66 FDA UDI
- Primary DI / UDI-DI
- 10885862037084 FDA UDI
- 510(k) Number
- K070479 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDILWJ FDA UDILPH FDA UDIJDI FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 FDA UDI888.3358 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
Dimensions & Sizes
- Size
- Outer Diameter — 66 Millimeter FDA UDI
Category: Acetabular shell
Novation by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070479 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 7ff0859d-1dd9-4a8d-b6ad-696b241144d1 35 fields · synced May 31, 2026