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FDA Product Code

FDA Product Code OVD — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3080

510(k) Clearances — 205 records · page 3 of 3

K-Number Device Name Applicant Decision Date Clearance Type Summary
K081501 SOLITAIRE ANTERIOR SPINAL SYSTEM Biomet Spine 2008-07-02 Traditional PDF ↗
K081395 SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM Biomet Spine 2008-06-25 Traditional PDF ↗
K073109 STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM Surgicraft , Ltd. 2008-06-04 Abbreviated PDF ↗
K072253 SYNFIX-LR SPACER Synthes Spine Co.Lp 2007-10-12 Traditional PDF ↗
K071922 INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC Rsb Spine, LLC 2007-09-18 Traditional PDF ↗

Product code OVD · Class II · Orthopedic. Data: openFDA.