510(k) K991552
- Device
- SYNTHES PEDIATRIC ROD SYSTEM
- Applicant
- SYNTHES (USA)
- 510(k) number
- K991552
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-06-02
- Date received
- 1999-05-03
- Regulation
- 888.3070
- Classification name
- Orthosis, Spondylolisthesis Spinal Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN GILBERT
- Address
- P.O. Box 1766 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 1000493591
- 3009380063
- 3007922509
- 9617544
- 3010326971
- 2029275
- 1000432246
- 9611274
- 3010057495
- 3012447612
- 2648623
- 1835831
- 3004635447
- 3010123256
- 3009149199
- 3004638600
- 3008285983
- 1528646
- 2032098
- 3009998573
- 3003387384
- 3010866843
- 1424434
- 8020776
- 3005819474
- 9611827
- 3043543260
- 3006404071
- 3009417901
- 1056553
- 3011795235
- 3009468807
- 3023138345
- 3010440433
- 3012381896
- 3011390763
- 1000200989
- 3013548554
- 3010120339
- 3010041430
- 1045254
- 3009882462
- 3009504230
- 3006082533
- 3005874553
- 2531477
- 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
- 2133687
- 1835251
- 3009509485
- 3020282716
- 3011489618
Source Documents#
Other 510(k) Records For Product Code MNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016-12-02 |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 |
| K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016-08-30 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| K153404 | Zavation Spinal System | Zavation, LLC | 2016-04-21 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016-03-02 |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| K151695 | Romeo posterior osteosynthesis system | Spineart | 2015-09-10 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015-06-26 |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015-04-29 |
| K142798 | PASS LP Spinal System | Medicrea International SA | 2015-03-25 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015-02-25 |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 |
Legacy Summary#
summary
FDA Review#
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