FDA 510(k) Applications Submitted by SHWETA SHARMA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210449 |
02/16/2021 |
InfinityÖ OCT System, PASS OCT« Spinal System |
Medtronic |
| K140417 |
02/18/2014 |
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
| K210637 |
03/03/2021 |
CD HorizonÖ Spinal System |
Medtronic |
| K191148 |
04/30/2019 |
Medtronic HV-RÖ Bone Cement, KyphonÖ XpedeÖ Bone Cement, CD HorizonÖ Fenestrated Screw Set |
Medtronic Sofamor Danek, USA Inc. |
| K201362 |
05/22/2020 |
CD HorizonÖ Fenestrated Screw Set, CD HorizonÖ Spinal System, KyphonÖ HV-RÖ Bone Cement |
Medtronic |
| K141599 |
06/13/2014 |
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
| K132639 |
08/23/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
| K142450 |
09/02/2014 |
DIVERGENCE Anterior Cervical Fusion System |
MEDTRONIC SOFAMOR DANEK USA, INC |
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