Identity
- Trade Name
- ATTUNE FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- ATTUNE KNEE SYSTEM REVISION CRS FIXED BEARING INSERT AOX 6MM SIZE 1 FDA UDI
- Model / Reference
- 1517-00-106 FDA UDI
- Description
- ATTUNE KNEE SYSTEM REVISION CRS FIXED BEARING INSERT AOX 6MM SIZE 1 FDA UDI
Identifiers
- Catalog Number
- 151700106 FDA UDI
- Primary DI / UDI-DI
- 10603295054368 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Tibial insert
Attune by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160700 also covers:
K241000 also covers:
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- P.F.C. — DEPUY (IRELAND)
- P.F.C. — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
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
- Depuy (ireland)
Sources (1)
- FDA UDI a1b42608-ce28-4d6c-8fc3-3648b55c36da 36 fields · synced May 30, 2026