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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
1.5MM TI CORTEX SCR SLF-TPNG WITH PLUSDRIVE(TM) RECESS 6MM FDA UDI
Model / Reference
400.036 FDA UDI
Description
1.5MM TI CORTEX SCR SLF-TPNG WITH PLUSDRIVE(TM) RECESS 6MM FDA UDI

Identifiers

Catalog Number
400036 FDA UDI
Primary DI / UDI-DI
20887587041930 FDA UDI
510(k) Number
K102656 FDA UDI
K162594 FDA UDI
K170818 FDA UDI
K980199 FDA UDI
FDA Product Code
JEY FDA UDI
DZL FDA UDI
MQN FDA UDI
PBJ FDA UDI
GMDN Term
Implantable craniofacial bone distractor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
872.4880 FDA UDI
882.5330 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

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

Similar devices

Also classified as Implantable craniofacial bone distractor.

Cleared under the same submission

K102656 also covers:

K162594 also covers:

K170818 also covers:

K980199 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI c73e5ff2-e359-47ee-9e37-c10a8875c375 36 fields · synced May 30, 2026