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Jet-X Central

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Jet-X Central FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Device Name
ANKLE SPAN- KIT STD CENTRAL BODY W TiN HALF PINS FDA UDI
Model / Reference
71051701 FDA UDI
Description
ANKLE SPAN- KIT STD CENTRAL BODY W TiN HALF PINS FDA UDI

Identifiers

Catalog Number
71051701 FDA UDI
Primary DI / UDI-DI
03596010613080 FDA UDI
510(k) Number
K994143 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
MRI Safety
MR Conditional FDA UDI

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

Jet-X Central by Smith & Nephew, 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

K994143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI e9086c54-f877-41f6-a99f-ed4a6d4e5167 36 fields · synced Jun 8, 2026