FLEXIBLE REAMER WITH Multiple Flute TIP, 9.5 MM
FDA UDIClass I (US FDA UDI)
by Biopro, Inc.
Identity
- Trade Name
- FLEXIBLE REAMER WITH Multiple Flute TIP, 9.5 MM FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Model / Reference
- 22388 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209223880 FDA UDI
- 510(k) Number
- K163627 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Bone-resection orthopaedic reamer, reusable
A flexible reamer with multiple flute tips, designed for orthopaedic surgical instruments intended to resect bone and relieve pressure at or facilitate access to joints. This reusable device is suitable for implantable applications where a prosthetic implant is typically attached.
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
K163627 also covers:
- 10MM NAIL CAP — BIOPRO, INC.
- 10MM NAIL CAP — BIOPRO, INC.
- 11MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 11MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 11MM NAIL CAP + 5MM — BIOPRO, INC.
- 11MM NAIL CAP + 5MM — BIOPRO, INC.
- 12MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 12MM NAIL CAP + 5MM — BIOPRO, INC.
- 13MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 13MM NAIL CAP — BIOPRO, INC.
- 14MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 15MM FUSION NAIL, LEFT — BIOPRO, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI fb2b7f67-8fc5-44fa-8209-5a4b16321764 33 fields · synced Jul 25, 2026