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Tenoglide®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Tenoglide® FDA UDI
Generic Name
Tendon spacer FDA UDI
Device Name
TenoGlide tendon protector sheet 2 in x 2 in (5cm x 5cm) FDA UDI
Model / Reference
TG221 FDA UDI
Description
TenoGlide tendon protector sheet 2 in x 2 in (5cm x 5cm) FDA UDI

Identifiers

Catalog Number
TG221 FDA UDI
Primary DI / UDI-DI
10381780032441 FDA UDI
510(k) Number
K053655 FDA UDI
FDA Product Code
FTM FDA UDI
GMDN Term
Tendon spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

Dimensions & Sizes

Size
Length — 5 Centimeter FDA UDI
Width — 2 Inch FDA UDI
Length — 2 Inch FDA UDI
Width — 5 Centimeter FDA UDI

Category: Tendon spacer

Tenoglide® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tendon spacer.

Cleared under the same submission

K053655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI bbe8c903-6276-4cf4-b80e-e0a2e76c84e2 38 fields · synced May 30, 2026