510(k) K963357
- Device
- MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
- Applicant
- SYNTHES (USA)
- 510(k) number
- K963357
- Product code
- MNH
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1997-01-09
- Date received
- 1996-08-26
- Regulation
- 888.3070
- Classification name
- Orthosis, Spondylolisthesis Spinal Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIANE T BROWN
- Address
- 1690 Russell Rd. Post Office Box 1766 Paoli PA US 19301 19301
FDA Registration Numbers#
- 3009051471
- 3004499989
- 3010197239
- 1526534
- 3010197224
- 9614209
- 3010120339
- 2183449
- 9611390
- 2032093
- 3004635447
- 2029005
- 2532027
- 3008114965
- 3010160527
- 3004941535
- 3010866843
- 3017528621
- 9617297
- 2530808
- 3009468807
- 3019837678
- 3011181154
- 3013011598
- 1828288
- 3010123206
- 3009882462
- 3009144915
- 3004142400
- 3023852420
- 3010120148
- 1030489
- 3009971621
- 3010041993
- 3010365473
- 1319660
- 3009173317
- 3010326971
- 3009887475
- 3006563559
- 3010120104
- 3005325790
- 3023138345
- 3009631939
- 3006846753
- 3009959868
- 1043653
- 1935627
- 3010162973
- 3015860552
- 1834331
- 3006356043
- 3036756245
- 3010057495
- 3002807561
- 1531174
- 3008110533
- 3010462278
- 1528646
- 2133928
- 3005083075
- 3000270450
- 3008583793
- 2029275
- 1835444
- 1526439
- 3005497913
- 3009973699
- 3002807112
- 3006404019
- 2032098
- 2183744
- 3008455034
- 1045254
- 3011390763
- 8010944
- 1828464
- 3003541440
- 3004717358
- 3005596514
Source Documents#
510(k) summary PDF not indicated by FDA
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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