Identity
- Trade Name
- ATTUNE FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- ATTUNE MAKE TO ORDER PS Femoral Notch Guide with Lugs and Saw Capture Size 7 FDA UDI
- Model / Reference
- 2999-66-315 FDA UDI
- Description
- ATTUNE MAKE TO ORDER PS Femoral Notch Guide with Lugs and Saw Capture Size 7 FDA UDI
Identifiers
- Catalog Number
- 299966315 FDA UDI
- Primary DI / UDI-DI
- 10603295494980 FDA UDI
- 510(k) Number
- K140881 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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 prosthesis implantation positioning instrument, reusable
Attune by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K140881 also covers:
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, INC.
- ATTUNE — DEPUY ORTHOPAEDICS, 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
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 3f5addd8-b460-4c6f-96a6-0454c0b222a5 36 fields · synced Jun 8, 2026