Identity
- Trade Name
- Burr Coarse 14MM FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Model / Reference
- 19534 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209195340 FDA UDI
- 510(k) Number
- K061089 FDA UDI
- FDA Product Code
- HTT FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medullary canal orthopaedic reamer, rigid
Burr Coarse 14MM by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, rigid.
- POLARSTEM — Smith & Nephew, Inc. · Class II
- Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
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- MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
- Panta® 2 — Ascension Orthopedics, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
Cleared under the same submission
K061089 also covers:
- Alignment Guide W/ Pin — BIOPRO, INC.
- Allen Key — BIOPRO, INC.
- Assembly Block — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- Bone Spatula — BIOPRO, INC.
- Burr Adaptor Microchoice — BIOPRO, INC.
- Burr Adaptor Stryker TPS — BIOPRO, INC.
- Burr Adaptor-Microaire — BIOPRO, INC.
- Burr Coarse 12MM — 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 |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 6528db44-0dfc-409a-92e3-2a1869b53627 33 fields · synced May 30, 2026