Identity
- Trade Name
- Tornier Humeral Nail FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Device Name
- Humeral Nail FDA UDI
- Model / Reference
- 0020600 FDA UDI
- Description
- Humeral Nail FDA UDI
Identifiers
- Catalog Number
- 0020600 FDA UDI
- Primary DI / UDI-DI
- 00846832091072 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDILength — 130 Millimeter FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
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 Arthrodesis intramedullary nail, non-distracting.
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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 d8888d43-bec5-4639-ab6d-4feff4f15c9c 37 fields · synced May 30, 2026