Identity
- Trade Name
- Gen II Cannulated Screws FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 7.3mm Cannulated Screw, 32mm Long Thread,56mm SS FDA UDI
- Model / Reference
- 00-1402-7356 FDA UDI
- Description
- 7.3mm Cannulated Screw, 32mm Long Thread,56mm SS FDA UDI
Identifiers
- Catalog Number
- 00-1402-7356 FDA UDI
- Primary DI / UDI-DI
- 00840194406635 FDA UDI
- 510(k) Number
- K190324 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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 Conditional FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Gen II Cannulated Screws by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K190324 also covers:
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP.
- OrthoPediatrics Cannulated Screw System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics Cannulated Screw System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics Cannulated Screw 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 45440691-c1d2-4c5a-bf52-b0ef3fd08e60 36 fields · synced May 29, 2026