Identity
- Trade Name
- Tornier Humeral Nail FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Cannulated Proximal Screw FDA UDI
- Model / Reference
- 7425036 FDA UDI
- Description
- Cannulated Proximal Screw FDA UDI
Identifiers
- Catalog Number
- 7425036 FDA UDI
- Primary DI / UDI-DI
- 00846832090297 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDILength — 36 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Tornier Humeral Nail by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K082754 also covers:
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
- Aequalis™ Humeral Nail — TORNIER, INC.
K230352 also covers:
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
- Tornier Humeral Nail — TORNIER, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI 105e1111-9339-4d3c-a81a-7f4a0bed0fb8 37 fields · synced May 30, 2026