Identity
- Trade Name
- Ossera™ AFX Instrumentation FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- Cannulated Convex Reamer, Ø46 FDA UDI
- Model / Reference
- 6741-4601-N FDA UDI
- Description
- Cannulated Convex Reamer, Ø46 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097522654 FDA UDI
- 510(k) Number
- K242356 FDA UDI
- FDA Product Code
- SAI FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone-resection orthopaedic reamer, reusable
Ossera™ AFX Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-resection orthopaedic reamer, reusable.
- InSitu Hip System — Nextstep Arthropedix · Class I
- Tornier Perform — TORNIER, INC. · Class I
- Arcos® STS™ Modular Revision System — Biomet Orthopedics, Inc. · Class II
- Vanguard® — Biomet Orthopedics, Inc. · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- LINK Instruments - Drills, reamers and saw blades — WALDEMAR LINK GmbH & Co. KG · Class I
Cleared under the same submission
K242356 also covers:
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
- Restor3D
Sources (1)
- FDA UDI 6ca16946-20f1-4843-b422-0ffbcbed39cf 34 fields · synced May 31, 2026