Gso Bone Fixation Fasteners

FDA 510(k) K063589 · Gold Standard Orthopaedics, LLC

Substantially Equivalent

510(k) numberK063589

Submission

Device name
Gso Bone Fixation Fasteners
Applicant
Gold Standard Orthopaedics, LLC
Louisville, KY, US
Received
December 1, 2006
Decision date
January 31, 2007
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 Gso Bone Fixation Fasteners cleared by the FDA?

Gso Bone Fixation Fasteners (K063589) received a 510(k) decision of Substantially Equivalent on January 31, 2007, 61 days after the submission was received.

What is the product code of K063589?

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