Identity
- Trade Name
- eZ-Fix FDA UDI
- Generic Name
- External orthopaedic fixation system noninvasive component, single-use FDA UDI
- Device Name
- Wrench, Cannulated 10mm L CP FDA UDI
- Model / Reference
- 910-CW-10L FDA UDI
- Description
- Wrench, Cannulated 10mm L CP FDA UDI
Identifiers
- Catalog Number
- 910-CW-10L FDA UDI
- Primary DI / UDI-DI
- 00841132142967 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system noninvasive component, 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: External orthopaedic fixation system noninvasive component, single-use
eZ-Fix by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External orthopaedic fixation system noninvasive component, single-use.
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- EF1 — Medshape, Inc. · Class II
- EF1 — Medshape, Inc. · Class II
- EF1 — Medshape, Inc. · Class II
Cleared under the same submission
K052196 also covers:
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
- eZ-Fix — ORTHOPEDIATRICS CORP.
K243798 also covers:
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — ORTHOPEDIATRICS CORP.
- Orthex External Fixation System — 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 2461ed8a-e43b-4832-a133-a32143457d9f 36 fields · synced May 30, 2026