Ligafix Interference Screw

FDA 510(k) K122228 · Sbm Sciences For Bio Materials

Substantially Equivalent

510(k) numberK122228

Submission

Device name
Ligafix Interference Screw
Applicant
Sbm Sciences For Bio Materials
Lourdes, FR
Received
July 26, 2012
Decision date
October 3, 2012
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAI – Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Ligafix Interference Screw cleared by the FDA?

Ligafix Interference Screw (K122228) received a 510(k) decision of Substantially Equivalent on October 3, 2012, 69 days after the submission was received.

What is the product code of K122228?

The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.