Identity
- Trade Name
- EPIX Assy, Long Nail 10mm x 280mm Right FDA UDI
- Generic Name
- Flexible intramedullary nail FDA UDI
- Device Name
- Intramedullary And Accessories FDA UDI
- Model / Reference
- 3210-28010R FDA UDI
- Description
- Intramedullary And Accessories FDA UDI
Identifiers
- Catalog Number
- 3210-28010R FDA UDI
- Primary DI / UDI-DI
- B221321028010R1 FDA UDI
- 510(k) Number
- K133104 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Flexible intramedullary nail 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 280 Millimeter FDA UDI
Category: Flexible intramedullary nail
EPIX Assy, Long Nail 10mm x 280mm Right by Epix Orthopaedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible intramedullary nail.
- T2 — Stryker Corp. · Class II
- T2 — Stryker Corp. · Class II
- T2 — Stryker Corp. · Class II
- T2 — Stryker Corp. · Class II
- T2 — Stryker Corp. · Class II
- Titanium Elastic Nail — Auxein Medical Private Limited · Class II
- T2 — Stryker Corp. · Class II
- MJ-FLEX — Orthofix, Inc. · Class II
Cleared under the same submission
K133104 also covers:
- EPIX Anti-Rotation Cap 0.0mm — Epix Orthopaedics Inc.
- EPIX Anti-Rotation Cap 10.0mm — Epix Orthopaedics Inc.
- EPIX Anti-Rotation Cap 15.0mm — Epix Orthopaedics Inc.
- EPIX Anti-Rotation Cap 5.0mm — Epix Orthopaedics Inc.
- EPIX AntiRotation Device — Epix Orthopaedics Inc.
- EPIX Assy, Long Nail 10mm x 280mm Left — Epix Orthopaedics Inc.
- EPIX Assy, Long Nail 10mm x 300mm Left — Epix Orthopaedics Inc.
- EPIX Assy, Long Nail 10mm x 300mm Right — Epix Orthopaedics Inc.
- EPIX Assy, Long Nail 10mm x 320mm Left — Epix Orthopaedics Inc.
- EPIX Assy, Long Nail 10mm x 320mm Right — Epix Orthopaedics Inc.
- EPIX Assy, Long Nail 10mm x 340mm Left — Epix Orthopaedics Inc.
- EPIX Assy, Long Nail 10mm x 340mm Right — Epix Orthopaedics 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 |
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Manufacturer
- Manufacturer
- Epix Orthopaedics Inc.
Sources (1)
- FDA UDI 1429fe94-c3ad-4536-b6db-09fe10e6e99c 37 fields · synced Jun 8, 2026