ROC LUMBAR PLATING SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Roc Lumbar Plating System.

Pre-market Notification Details

Device IDK090228
510k NumberK090228
Device Name:ROC LUMBAR PLATING SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
ContactKarla Schaffner
CorrespondentKarla Schaffner
ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-30
Decision Date2009-04-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840967193632 K090228 000
00840967194134 K090228 000
00840967194141 K090228 000
00840967194202 K090228 000
00840967194219 K090228 000
00840967194257 K090228 000
00840967194271 K090228 000
00840967194288 K090228 000
00840967194295 K090228 000
00840967194301 K090228 000
00840967194127 K090228 000
00840967193960 K090228 000
00840967193953 K090228 000
00840967193649 K090228 000
00840967193656 K090228 000
00840967193687 K090228 000
00840967193779 K090228 000
00840967193786 K090228 000
00840967193885 K090228 000
00840967193892 K090228 000
00840967193908 K090228 000
00840967193946 K090228 000
00840967194349 K090228 000
00840967194516 K090228 000
00840967194523 K090228 000
00844856021723 K090228 000
00844856021730 K090228 000
00844856021808 K090228 000
00844856021822 K090228 000
00844856021839 K090228 000
00844856021846 K090228 000
00844856021853 K090228 000
00844856031548 K090228 000
00844856045422 K090228 000
00844856021693 K090228 000
00844856021686 K090228 000
00844856021679 K090228 000
00840967194530 K090228 000
00840967194752 K090228 000
00840967194769 K090228 000
00840967194813 K090228 000
00840967194868 K090228 000
00840967194875 K090228 000
00844856021617 K090228 000
00844856021624 K090228 000
00844856021648 K090228 000
00844856045439 K090228 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.