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Distraction, External

FDA UDI

Class II (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
DISTRACTION, EXTERNAL FDA UDI
Generic Name
Implantable craniofacial bone distractor FDA UDI
Device Name
SCREW, HEX, RED 2, HALO FIXATION, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM FDA UDI
Model / Reference
51-575-13-91 FDA UDI
Description
SCREW, HEX, RED 2, HALO FIXATION, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM FDA UDI

Identifiers

Primary DI / UDI-DI
00888118108463 FDA UDI
FDA Product Code
MQN FDA UDI
GMDN Term
Implantable craniofacial bone distractor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Implantable craniofacial bone distractor

Distraction, External by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable craniofacial bone distractor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
KLS-Martin L.P.

Sources (1)

  • FDA UDI 406f5ea1-fc35-422d-9afb-d1c9a327a243 35 fields · synced May 30, 2026