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Optilink

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
OPTILINK FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
5.0MM PERIPR VAL SCR/10MM OPTILINK(TM)/STRDRV/STERILE FDA UDI
Model / Reference
42.231.010S FDA UDI
Description
5.0MM PERIPR VAL SCR/10MM OPTILINK(TM)/STRDRV/STERILE FDA UDI

Identifiers

Catalog Number
42231010S FDA UDI
Primary DI / UDI-DI
10886982259202 FDA UDI
510(k) Number
K162124 FDA UDI
FDA Product Code
JDQ FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Optilink 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

K162124 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 13fbea67-b131-4251-ae4c-392b86a5ad42 36 fields · synced May 30, 2026