510(k) K091944
- Device
- MODIFICATION TO: DSS STABILIZATION SYSTEM
- Applicant
- PARADIGM SPINE, LLC
- 510(k) number
- K091944
- Product code
- NQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-08-03
- Date received
- 2009-06-30
- Regulation
- 888.3070
- Classification name
- Posterior Metal/polymer Spinal System, Fusion
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ADAM HERDER
- Address
- 1331 H St. NW 12th Floor Washington DC US 20005 20005
FDA Registration Numbers#
- 8043792
- 3005677016
- 3020282716
- 3004142400
- 1045254
- 3010123206
- 3010287737
- 3014725904
- 1824199
- 3030412764
- 2647346
- 3003761012
- 3013176080
- 3011795235
- 3003595343
- 3006639944
- 3005144609
- 3004188066
- 3015207155
- 2133928
- 3010120135
- 3035366890
- 3009888740
- 1833920
- 3006846753
- 3018094310
- 3010863450
- 2032112
- 3002807561
- 3010032903
- 1526534
- 3008793310
- 3010120104
- 3009217531
- 3009973336
- 3010160527
- 1030489
- 3010047454
- 3003120897
- 3019767615
- 2134285
- 3011277306
Source Documents#
Other 510(k) Records For Product Code NQP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203678 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021-01-15 |
| K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-10-03 |
| K182928 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-01-11 |
| K133164 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2014-01-16 |
| K101704 | ZIMMER DTO PIN PRESS INSTRUMENT | Zimmer Spine, Inc. | 2010-08-18 |
| K101083 | DSS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2010-07-02 |
| K092234 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2009-10-01 |
| K073439 | TRANSITION STABILIZATION SYSTEM | Globus Medical, Inc. | 2009-02-20 |
| K080241 | DDS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2008-11-28 |
| K080963 | DSS STABILIZATION SYSTEM | Paradigm Spine | 2008-05-02 |
| K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER | Scient'X | 2008-04-17 |
| K072321 | BIOFLEX | Biospine Co., Ltd. | 2008-03-25 |
| K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2008-02-08 |
| K072969 | DSS | Paradigm Spine, LLC | 2008-01-24 |
| K072685 | NGARDE SYSTEM | N Spine, Inc. | 2007-10-19 |
Legacy Summary#
summary
FDA Review#
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