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FDA Product Code

FDA Product Code MNH — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3070

510(k) Clearances — 309 records · page 4 of 4

K-Number Device Name Applicant Decision Date Clearance Type Summary
K944737 ISOLA SPINE SYSTEM Acromed Corp. 1995-06-22 Traditional PDF ↗
K930353 SIMMONS PLATING SYSTEM BOLT AND SCREW Smith & Nephew, Inc. 1995-06-20 Traditional PDF ↗
K930298 ROGOZINSKI SPINAL ROD SYSTEM SCREW Smith & Nephew Richards, Inc. 1995-06-14 Traditional PDF ↗
K944756 ISOLA OPEN AND CLOSED SCREWS Acromed Corp. 1995-05-30 Traditional PDF ↗
K944736 VSP (VARIABLE SCREW PLACEMENT) Acromed Corp. 1995-05-05 Traditional PDF ↗
K945064 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. 1995-04-26 Traditional PDF ↗
K943775 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. 1995-04-26 Traditional PDF ↗
K942387 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. 1995-02-14 Traditional PDF ↗
K932029 TSRH SPINAL SCREWS Sofamor Danek Mfg., Inc. 1995-01-20 Traditional PDF ↗

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