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PlusDrive

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
PlusDrive FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 18MM FDA UDI
Model / Reference
401.299E FDA UDI
Description
2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 18MM FDA UDI

Identifiers

Catalog Number
401299E FDA UDI
Primary DI / UDI-DI
10887587046686 FDA UDI
510(k) Number
K974555 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) 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: Orthopaedic bone screw (non-sliding)

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

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Cleared under the same submission

K974555 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 9ad0d9d8-a357-4c80-8a88-2296ebaa9e99 36 fields · synced May 30, 2026