Matryx Interference Screw (5.0-6.5MM)

FDA 510(k) K102410 · Conmed Linvatec

Substantially Equivalent

510(k) numberK102410

Submission

Device name
Matryx Interference Screw (5.0-6.5MM)
Applicant
Conmed Linvatec
Largo, FL, US
Received
August 24, 2010
Decision date
December 21, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HWC – Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Matryx Interference Screw (5.0-6.5MM) cleared by the FDA?

Matryx Interference Screw (5.0-6.5MM) (K102410) received a 510(k) decision of Substantially Equivalent on December 21, 2010, 119 days after the submission was received.

What is the product code of K102410?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.