Identity
- Trade Name
- ORTHO SOLUTIONS STERILE DRILL BITS FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- 3.5MM CANN SCREW CANNULATED DRILL 2.5MM (FPS) FDA UDI
- Model / Reference
- OS200325 FDA UDI
- Description
- 3.5MM CANN SCREW CANNULATED DRILL 2.5MM (FPS) FDA UDI
Identifiers
- Catalog Number
- OS200325 FDA UDI
- Primary DI / UDI-DI
- 05055662931402 FDA UDI
- 510(k) Number
- K102743 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Cannulated surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
No
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
No
FDA UDI
Category: Cannulated surgical drill bit, reusable
Ortho Solutions Sterile Drill Bits by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, reusable.
- Thunderbolt — RESPONSIVE ORTHOPEDICS LLC · Class I
- 4.0 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc · Class II
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC · Class I
- EBA2 — Citieffe · Class II
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- DynaNail — Medshape, Inc. · Class I
- BIXCUT — Stryker Corp. · Class I
- FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I
Cleared under the same submission
K102743 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
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
- Ortho Solutions Holdings Limited
Sources (1)
- FDA UDI 53d97c65-bd23-4c1e-a047-1ab76dab2378 36 fields · synced May 31, 2026