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#
- 2183946
- 3006272282
- 3010440433
- 3025603301
- 9611274
- 1000200989
- 1000577893
- 3010365473
- 3012711663
- 3011489618
- 3010370554
- 9617297
- 3012491394
- 3004024955
- 1223434
- 3012329926
- 9610612
- 1835831
- 3009169996
- 3014252644
- 3012381896
- 3006639944
- 1000517406
- 3040335671
- 3005076207
- 3009380063
- 1319660
- 3006791286
- 3007353762
- 1000432246
- 3010047454
- 2028632
- 3007923096
- 3014725904
- 3004188066
- 3036756245
- 1644312
- 1226544
- 3003477135
- 2032098
- 3009050824
- 2133687
- 1528646
- 2031093
- 2648666
- 3016496998
- 3005819474
- 3007922509
- 3011221483
- 3011818499
- 3019767615
- 3003525643
- 3008455034
- 3008749819
- 3005596514
- 1000461041
- 2032112
- 9611390
- 3007728266
- 3008992889
- 1835572
- 3015967359
- 9616944
- 3000170817
- 3015941638
- 3008868758
- 3019837678
- 3009110133
- 3009051471
- 1056553
- 2135156
- 3003120897
- 1526534
- 1721676
- 3003541440
- 9614841
- 3003639920
- 1835251
- 3002976036
- 9612420
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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