Identity
- Trade Name
- SCREW D.C. 1.5 x 50mm FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Model / Reference
- 17114 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209171140 FDA UDI
- 510(k) Number
- K963433 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, sterile
SCREW D.C. 1.5 x 50mm by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
- EPS Plating System Screw — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- A.L.P.S.CORTICAL SCREW — Biomet Orthopedics, Inc. · Class II
- Peri-Loc — Smith & Nephew, Inc. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- MAX VPC™VARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
Cleared under the same submission
K963433 also covers:
- Installation Driver — BIOPRO, INC.
- Removal Driver — BIOPRO, INC.
- SCREW D.C. 1.5 x 20mm — BIOPRO, INC.
- SCREW D.C. 1.5 x 25mm — BIOPRO, INC.
- SCREW D.C. 1.5 x 30mm — BIOPRO, INC.
- SCREW D.C. 1.5 x 35mm — BIOPRO, INC.
- SCREW D.C. 1.5 x 40mm — BIOPRO, INC.
- SCREW D.C. 1.5 x 45mm — BIOPRO, INC.
- SCREW D.C. 1.5 x 55mm — BIOPRO, INC.
- SCREW D.C. 1.8 x 20mm — BIOPRO, INC.
- SCREW D.C. 1.8 x 25mm — BIOPRO, INC.
- SCREW D.C. 1.8 x 30mm — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI a182c857-7122-4e14-a9ad-629bc4a97544 33 fields · synced Jun 1, 2026