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BioTritis

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
BioTritis FDA UDI
Generic Name
Meniscus screw FDA UDI
Device Name
Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and Trocar Tip Drill/Drill Guide FDA UDI
Model / Reference
2111SS FDA UDI
Description
Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and Trocar Tip Drill/Drill Guide FDA UDI

Identifiers

Primary DI / UDI-DI
10884521513341 FDA UDI
510(k) Number
K060522 FDA UDI
FDA Product Code
MAI FDA UDI
GMDN Term
Meniscus screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 38 Millimeter FDA UDI
Width — 8 Millimeter FDA UDI

Category: Meniscus screw

BioTritis by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Meniscus screw.

Cleared under the same submission

K060522 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 6d8604ff-2447-4884-9a2c-10daa3907e84 36 fields · synced Jun 6, 2026