510(k) K021880
- Device
- CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
- Applicant
- DEPUY ACROMED
- 510(k) number
- K021880
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-26
- Date received
- 2002-06-07
- 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
- LISA GILMAN
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3004142400
- 3016050940
- 9617544
- 3005677016
- 1531174
- 3001239363
- 3008868758
- 3015869121
- 1221763
- 3010509633
- 3014763043
- 9611813
- 1423662
- 3010009693
- 3003541440
- 3014252644
- 3009882675
- 3008749819
- 3009106092
- 3003526896
- 3011513267
- 3009504230
- 3009169996
- 1000517406
- 3013055499
- 2133687
- 8010944
- 3007728266
- 3011390763
- 2032093
- 3014273424
- 1056553
- 3010370554
- 3005596514
- 3031240334
- 3006563559
- 1223434
- 3017036472
- 3009973699
- 2031917
- 2183744
- 3015941638
- 3017435639
- 3005083075
- 2031966
- 1424434
- 1528646
- 1530390
- 1649379
- 3014655115
- 1000493591
- 3011874600
- 3015399803
- 1834331
- 3003761012
- 9614209
- 1225838
- 3011489618
- 3003855635
- 2531195
- 3010287685
- 1835572
- 3014725904
- 1529009
- 3009973505
- 3015440604
- 3018210489
- 3009882462
- 3008850074
- 1043653
- 3009973336
- 3002976036
- 3016261131
- 3010462278
- 3005325790
- 3011221483
- 2029275
- 3010120326
- 3010047454
- 3010606097
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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