Identity
- Trade Name
- GUIDING HANDLE FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Model / Reference
- 18650 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810012484152 FDA UDI
- 510(k) Number
- K101030 FDA UDI
- FDA Product Code
- HWA FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use 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
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
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Guiding Handle by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
- MyKnee PPS — Medacta International · Class II
- MyKnee — Medacta International · Class II
- MyKnee PPS — Medacta International · Class II
- MyKnee — Medacta International · Class II
- MyKnee — Medacta International · Class II
- My Knee Tibial Cutting Blocks MIS — Medacta International · Class II
- My Spine Low Profile Placement Guides — Medacta International · Class II
- MySpine Unilateral Guide — Medacta International · Class II
Cleared under the same submission
K101030 also covers:
- 10MM X 3 HBS STD COMP - S. C. — BIOPRO, INC.
- 10mm HBS® High Compression — BIOPRO, INC.
- 10mm x 2.5 HBS Sd Comp — BIOPRO, INC.
- 12MM X 3.0 HBS SCREW SDST PKG — BIOPRO, INC.
- 12mm HBS® High Compression — BIOPRO, INC.
- 13mm HBS® Standard Compression — BIOPRO, INC.
- 13mm x 3 HBS High Comp - S. C. — BIOPRO, INC.
- 14MM X 3.0 HBS SCREW SDST PKG — BIOPRO, INC.
- 14mm HBS® High Compression — BIOPRO, INC.
- 14mm HBS® Standard Compression — BIOPRO, INC.
- 15mm x 2.5 HBS Sd Comp — BIOPRO, INC.
- 16MM X 2.5 HBS STD COMP-S.C. — 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 cbef246d-ec45-4497-b951-7a4ff7e7d2c3 33 fields · synced Jun 1, 2026