Identity
- Trade Name
- eZ-Fix FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- Half Pin, 3.0 x 75mm w/ 25mm TL FDA UDI
- Model / Reference
- 530-075-25 FDA UDI
- Description
- Half Pin, 3.0 x 75mm w/ 25mm TL FDA UDI
Identifiers
- Catalog Number
- 530-075-25 FDA UDI
- Primary DI / UDI-DI
- 00841132142400 FDA UDI
- 510(k) Number
- K052196 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable 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
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: Orthopaedic bone pin, non-bioabsorbable
eZ-Fix by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
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- IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
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- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
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- SMART TSF — Smith & Nephew, 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.
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 e6eec112-0698-4dd7-8366-6c0795fba882 36 fields · synced Jun 1, 2026