Identity
- Trade Name
- Dynex FDA UDI
- Generic Name
- Surgical traction tensioner connector FDA UDI
- Device Name
- Nose, Short, Tensioner FDA UDI
- Model / Reference
- DSF-XFX-625-12L FDA UDI
- Description
- Nose, Short, Tensioner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731125972 FDA UDI
- 510(k) Number
- K202054 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical traction tensioner connector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Category: Surgical traction tensioner connector
Dynex by Vilex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical traction tensioner connector.
- eZ-Fix Tool — VILEX IN TENNESSEE, INC. · Class I
- TRACTION HOOK EXTENDER — Mizuho Orthopedic Systems, Inc. · Class I
- PEDIATRIC BOW WITH FINGER TRAP SET — Mizuho Orthopedic Systems, Inc. · Class I
- eZ-Fix Tool — ORTHOPEDIATRICS CORP. · Class I
- BOW WITH FINGER TRAP SET — Mizuho Orthopedic Systems, Inc. · Class I
- eZ-Fix Tool — ORTHOPEDIATRICS CORP. · Class I
- PROFX TRACTION BOOT ADAPTOR ASSY, REFURBISHED — Mizuho Orthopedic Systems, Inc. · Class I
- HANA/PROFX 90 DEG PIN AND WIRE HOLDER, REFURBISHED — Mizuho Orthopedic Systems, Inc. · Class I
Cleared under the same submission
K202054 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Vilex, Inc.
Sources (1)
- FDA UDI 39e62f89-4fe2-47ff-8844-3380b5d361a7 34 fields · synced May 30, 2026