Identity
- Trade Name
- ORIF Standard Calc plate, long FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 20915 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209209150 FDA UDI
- 510(k) Number
- K162674 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
ORIF Standard Calc plate, long by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
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- Summa Orthopaedics Wrist System Bone Plate — Jeil Medical Corporation · Class II
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- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
- TUBULAR PLATE — Biomet Orthopedics, Inc. · Class II
- APTUS — Medartis Inc. · Class II
Cleared under the same submission
K162674 also covers:
- 1/3 Locking Tubular Plate 2 Hole, Sterile — BIOPRO, INC.
- Anterior Lateral Tibia Plate 5 Hole, right, Sterile — BIOPRO, INC.
- Cloverleaf Plate 3 holes 2.5/2.8mm Sterile — BIOPRO, INC.
- Cortical Locking Screw 3.5mm x 24mm Sterile — BIOPRO, INC.
- Cortical Locking Screw 3.5mm x 35mm Sterile — BIOPRO, INC.
- Cortical Locking Screw 3.5mm x 50mm Sterile — BIOPRO, INC.
- Cortical Locking Screw 4.0mm x 100mm — BIOPRO, INC.
- Cortical Locking Screw 4.0mm x 30mm Sterile — BIOPRO, INC.
- Cortical Locking Screw 4.0mm x 75mm Sterile — BIOPRO, INC.
- Cortical Locking Screw, 4.0mm x 36mm — BIOPRO, INC.
- Cortical Screw 2.0mm x 14mm Sterile — BIOPRO, INC.
- Cortical Screw 2.0mm x 16mm — 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 |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI b80295dd-f7f5-47c4-9401-773a5df38be4 33 fields · synced Jun 8, 2026