← Back to catalogue
FLEXIBLE REAMER WITH Multiple Flute TIP, 12.5 MM
FDA UDIClass I (US FDA UDI)
by Biopro, Inc.
Identity
- Trade Name
- FLEXIBLE REAMER WITH Multiple Flute TIP, 12.5 MM FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Model / Reference
- 22393 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209223930 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-resection orthopaedic reamer, reusable
FLEXIBLE REAMER WITH Multiple Flute TIP, 12.5 MM by Biopro, Inc. — Class I — 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
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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 1d513274-496f-43b0-b61c-af39d6f56bad 33 fields · synced Jun 1, 2026