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Trigen

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Trigen FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Device Name
6.4MM X 105MM CAPTURED RECON SCREW BLUE FDA UDI
Model / Reference
71632305 FDA UDI
Description
6.4MM X 105MM CAPTURED RECON SCREW BLUE FDA UDI

Identifiers

Catalog Number
71632305 FDA UDI
Primary DI / UDI-DI
03596010393067 FDA UDI
510(k) Number
K981529 FDA UDI
FDA Product Code
JDS FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Trigen by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K981529 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI fd05ce85-6ccb-4ef7-b23e-a5f242b25743 37 fields · synced Jun 8, 2026