PlusDrive

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: PlusDrive FDA UDI
Generic Name: Implantable craniofacial bone distractor FDA UDI
Device Name: 1.2MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 8MM FDA UDI
Model / Reference: 400.468 FDA UDI
Description: 1.2MM TI EMERGENCY SCREW WITH PLUSDRIVE(TM) RECESS 8MM FDA UDI

Identifiers

Catalog Number: 400468 FDA UDI
Primary DI / UDI-DI: 20887587043422 FDA UDI
510(k) Number: K912932 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Implantable craniofacial bone distractor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Implantable craniofacial bone distractor

PlusDrive by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable craniofacial bone distractor.

DISTRACTION, INTERNAL, STERILE — KLS-Martin L.P. · Class II
DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
OsteoMed — Osteomed Corp. · Class II
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC · Class II
DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
DISTRACTION, EXTERNAL — KLS-Martin L.P. · Class II

Cleared under the same submission

K912932 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 II	Pending data

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Manufacturer

Manufacturer: Synthes

Sources (1)

FDA UDI 041d681d-14c3-496c-917a-be34bc39eed0 36 fields · synced May 30, 2026