Arthrex Bio-Transfix

FDA 510(k) K011172 · Arthrex, Inc.

Substantially Equivalent

510(k) numberK011172

Submission

Device name
Arthrex Bio-Transfix
Applicant
Arthrex, Inc.
Naples, FL, US
Received
April 17, 2001
Decision date
June 19, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNU – Staple, Absorbable
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K212594OSSIOfiber® StapleMNU · Traditional OSSIO , Ltd.01/21/2022SE

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Questions and answers

When was Arthrex Bio-Transfix cleared by the FDA?

Arthrex Bio-Transfix (K011172) received a 510(k) decision of Substantially Equivalent on June 19, 2001, 63 days after the submission was received.

What is the product code of K011172?

The FDA product code is MNU – Staple, Absorbable, a Class II (moderate risk) device regulated under 21 CFR 888.3030.