510(k) K990745
- Device
- MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
- Applicant
- SYNTHES SPINE
- 510(k) number
- K990745
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-30
- Date received
- 1999-03-08
- Regulation
- 888.3070
- Classification name
- Orthosis, Spinal Pedicle Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- J0NATHAN GILBERT
- Address
- P.O. Box 0548 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 1000493591
- 3009380063
- 3007922509
- 9617544
- 3006849754
- 3010326971
- 2029275
- 3004111573
- 1000432246
- 9611274
- 3010057495
- 3012447612
- 2648623
- 1835831
- 3004635447
- 3010123256
- 3009149199
- 3004638600
- 3008285983
- 1528646
- 2032098
- 3009998573
- 3003387384
- 3040335671
- 3010866843
- 1424434
- 8020776
- 3005819474
- 9611827
- 3043543260
- 3006404071
- 3009417901
- 1724955
- 1056553
- 3011795235
- 3009468807
- 3023138345
- 3010440433
- 3012381896
- 3011390763
- 1000200989
- 3013548554
- 3010120339
- 3010041430
- 1045254
- 3009882462
- 3009504230
- 3006082533
- 3005874553
- 2531477
- 3008132398
- 8010944
- 3011187779
- 2183744
- 2530808
- 3012863589
- 3008102042
- 1423662
- 3003541440
- 3010370554
- 3003526896
- 3006272282
- 2134947
- 3013055499
- 3009973505
- 3015399803
- 3006356043
- 3010531060
- 3010178296
- 3000170817
- 3010123206
- 3010120135
- 2532027
- 3025603301
- 3014763043
- 3015869493
- 3015398319
- 2031917
- 9616944
- 3010365473
Source Documents#
Other 510(k) Records For Product Code MNI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016-08-22 |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016-06-29 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | 2016-04-04 |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015-12-11 |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 |
| K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 |
Legacy Summary#
summary
FDA Review#
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