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Dynex

FDA UDI

Class II (US FDA UDI)

by Vilex, Inc.

Identity

Trade Name
Dynex FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Device Name
Half Pin, 6.0x200x55 Button HA, Sterile Pkgd FDA UDI
Model / Reference
DS-HP60-200-55B FDA UDI
Description
Half Pin, 6.0x200x55 Button HA, Sterile Pkgd FDA UDI

Identifiers

Primary DI / UDI-DI
00841731126405 FDA UDI
510(k) Number
K202054 FDA UDI
FDA Product Code
JDW FDA UDI
GMDN Term
External orthopaedic fixation system, single-use, sterile 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External orthopaedic fixation system, single-use, sterile

Dynex by Vilex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, single-use, sterile.

Cleared under the same submission

K202054 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vilex, Inc.

Sources (1)

  • FDA UDI 2c704737-aa7a-4f6c-b1ca-d74bbc079d0c 34 fields · synced Jun 8, 2026