510(k) K093670
- Device
- MODIFICATION TO: OASYS SYSTEM
- Applicant
- STRYKER SPINE
- 510(k) number
- K093670
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-18
- Date received
- 2009-11-27
- 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
- PAULINE SHAND
- Address
- 2 Pearl Ct. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 9617297
- 1226544
- 3023265483
- 3007993775
- 3007485169
- 3006846753
- 3011221483
- 3010866843
- 1000493591
- 3009554293
- 3005819474
- 3006563559
- 2032830
- 3015869121
- 3043543260
- 3010370880
- 2531477
- 3036756245
- 3006404019
- 3034676720
- 1828288
- 3011556898
- 3015941638
- 3009882462
- 2133687
- 3008526708
- 3006217744
- 3016443334
- 3010120326
- 3004893332
- 2531195
- 2530808
- 2028632
- 3010041993
- 1043214
- 3010120135
- 3008110533
- 3009169872
- 2032112
- 3031240334
- 3014252644
- 1526439
- 1527105
- 1221763
- 3004774118
- 3008102042
- 2029275
- 3010041430
- 3009504230
- 1424263
- 3000170817
- 3007353762
- 3005562917
- 3016261131
- 3003935342
- 3009173317
- 3008959459
- 3012711663
- 3018210489
- 2032093
- 3025457095
- 3010509633
- 2647346
- 3020282716
- 3011390763
- 9610612
- 1000432246
- 3008868758
- 8020776
- 8043792
- 1835572
- 3008262872
- 3008749819
- 3005180920
- 3005706667
- 1225838
- 3012491394
- 2134285
- 3005977257
- 3009887475
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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