NQP

Product Code: NQP


Products Classified as NQP

4647Posterior Metal/polymer Spinal System, FusionThoracolumbosacral Pedicle Screw System.

Total Product Life Cycle (TPLC) Devices

4647Posterior Metal/polymer Spinal System, FusionThoracolumbosacral Pedicle Screw System.

FDA Consensus Standards

Posterior Metal/Polymer Spinal System, Fusion [37410]21 CFR §888.3070 🔎
Posterior Metal/Polymer Spinal System, Fusion [37411]21 CFR §888.3070 🔎
Posterior Metal/Polymer Spinal System, Fusion [35610]21 CFR §888.3070 🔎

Pre-market Notifications for NQP

K203678CD HORIZONâ„¢ Spinal SystemMedtronic Sofamor Danek USA, INC.
K191066CD Horizonâ„¢ Astuteâ„¢ Spinal SystemMedtronic Sofamor Danek, USA Inc.
K182928CD Horizonâ„¢ Spinal SystemMedtronic Sofamor Danek USA, Inc.
K133164DYNESYS TOP-LOADING SPINAL SYSTEMZIMMER SPINE, INC
K101704ZIMMER DTO PIN PRESS INSTRUMENTZIMMER SPINE, INC.
K101083DSS STABILIZATION SYSTEMPARADIGM SPINE LLC
K092234DYNESYS TOP-LOADING SPINAL SYSTEMZIMMER SPINE, INC
K091944MODIFICATION TO: DSS STABILIZATION SYSTEMPARADIGM SPINE, LLC
K080963DSS STABILIZATION SYSTEMPARADIGM SPINE
K080241DDS STABILIZATION SYSTEMPARADIGM SPINE, LLC
K073347DYNESYS TOP-LOADING SPINAL SYSTEMZIMMER SPINE, INC
K072969DSSPARADIGM SPINE, LLC
K072685NGARDE SYSTEMN SPINE, INC.
K072321BIOFLEXBIOSPINE CO., LTD.
K071879ZIMMER DTO IMPLANTZIMMER SPINE, INC

Global Unique Device Identification Database

00426014889692Posterior Metal/Polymer Spinal System, Fusion
00613994929518POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994929471POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994929457POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994929426POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994929402POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994929372POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994842589POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994792778POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994792631POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994776464POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994651808POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994651785POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994651778POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
00613994651747POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Maude Adverse Events

DYNESYS SCREWZIMMER GMBH2020-03-04
DYNESYS SCREW SPINE IMPL WINZIMMER GMBH2020-02-28
DYNESYS SPINE IMPL WIN GENZIMMER GMBH2020-02-28
DYNESYS SPINE IMPL WIN GENZIMMER GMBH2020-02-28
DYNESYS SPINE IMPLANTZIMMER GMBH2020-02-28
DYNESYS SPINE IMPLANTZIMMER GMBH2020-02-28
DYNESYS SPINE IMPL WIN GENZIMMER GMBH2020-02-28
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2020-02-14
DYNESYS LIS, STABILIZING CORD, 100ZIMMER GMBH2020-02-05
DYNESYS, PEDICLE SCREW + SET SCREW, 6.4X50ZIMMER GMBH2020-01-06
DYN PEDICLE+SET SCR 6.4X50 2 XZIMMER GMBH2019-08-22
UNKNOWN DYNESYS SPINE IMPLANTZIMMER GMBH2019-05-21
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2019-05-17
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2019-05-02
DYNESYS, COUNTER TORQUE HANDLEZIMMER GMBH2019-04-12
DYNESIS HA PEDICLE+SET SCR 6.0X40ZIMMER GMBH2019-03-16
DTL SPACER CUTTERZIMMER BIOMET SPINE INC.2018-11-13
DYNESYS SCREW SPINEZIMMER GMBH2018-10-17
DYNESYS L I S FUSION CORD 200ZIMMER GMBH2018-09-14
DYNESYSTL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-08-10
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-08-10
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2018-08-03
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-07-04
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-07-04
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2018-07-04
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-07-04
DYNESYSTL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-07-03
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 7.2X50ZIMMER GMBH2018-07-03
DYNESYS TL, SET SCREWZIMMER GMBH2018-07-03
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-07-03
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2018-07-03
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40ZIMMER GMBH2018-06-29
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2018-06-29
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-06-29
DYNESYS REVISION SCREW + SET SCREW, 7.2X40ZIMMER GMBH2018-06-19
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-04-27
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40ZIMMER GMBH2018-04-19
DYNESYSZIMMER2018-03-22
DYNESYS LIS, STABILIZING CORD, 100ZIMMER GMBH2018-03-15
TRANSITIONGLOBUS MEDICAL, INC.2018-02-26
TRANSITIONGLOBUS MEDICAL, INC.2018-02-22
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35ZIMMER GMBH2018-02-06
DYNESYS LIS, STABILIZING CORD, 200ZIMMER GMBH2018-02-06
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40ZIMMER GMBH2018-02-06
DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X45ZIMMER GMBH2018-02-06
DYNESYS LIS, STABILIZING CORD, 100ZIMMER GMBH2017-12-21
DYNESYS CORDZIMMER GMBH2017-12-11
DSS STABILIZATION SYSTEMPARADIGM SPINE GMBH2017-10-13
RODSYNTHES USA2017-09-21
RODSYNTHES USA2017-09-21
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