Identity
- Trade Name
- Drive Rail FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- Clamp Rotational Mount FDA UDI
- Model / Reference
- 20-1203 FDA UDI
- Description
- Clamp Rotational Mount FDA UDI
Identifiers
- Catalog Number
- 20-1203 FDA UDI
- Primary DI / UDI-DI
- 00817867020030 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: External orthopaedic fixation system, single-use
Drive Rail by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
- TRUELOK EVO — Orthofix, Inc. · Class II
- Monkey Rings™ External Fixation System — Paragon 28 · Class II
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- TrueLok — Orthofix, Inc. · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
Cleared under the same submission
K140822 also covers:
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
K220809 also covers:
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
- Drive Rail — ORTHOPEDIATRICS CORP.
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
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 5b9c1a0f-1732-45ae-a470-a9b6896b65ee 36 fields · synced Jun 6, 2026