510(k) K133288
- Device
- CASPIAN OCT SPINAL SYSTEM
- Applicant
- K2M, INC.
- 510(k) number
- K133288
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-01
- Date received
- 2013-10-25
- Regulation
- 888.3050
- Classification name
- Appliance, Fixation, Spinal Interlaminal
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NANCY GIEZEN
- Address
- 751 Miller Dr. SE Leesburg VA US 20175 20175
FDA Registration Numbers#
- 1000493591
- 3009380063
- 3007922509
- 9617544
- 2029275
- 1000432246
- 3010057495
- 3012447612
- 2648623
- 1835831
- 3004635447
- 3010123256
- 3009149199
- 3008285983
- 1528646
- 2032098
- 3009998573
- 3003387384
- 3010866843
- 1424434
- 8020776
- 3005819474
- 9611827
- 3043543260
- 3009540749
- 3009417901
- 3015179588
- 1056553
- 3011795235
- 3023138345
- 3022159082
- 3010440433
- 1833824
- 1000200989
- 3013548554
- 3010120339
- 3010041430
- 1045254
- 3009504230
- 3005874553
- 2531477
- 8010944
- 3011187779
- 2530808
- 3013514648
- 1423662
- 3003541440
- 3010370554
- 3003526896
- 3011170410
- 3006272282
- 2134947
- 3013055499
- 3009973505
- 3015399803
- 3006356043
- 3010178296
- 3000170817
- 3010123206
- 3010120135
- 2532027
- 3025603301
- 3015869493
- 3015398319
- 2031917
- 3012131184
- 3010365473
- 2133687
- 1835251
- 3009509485
- 3020282716
- 1834331
- 3007539489
- 3004774118
- 3037407500
- 3017435639
- 3008110533
- 3009144915
- 1450662
- 3006128100
Source Documents#
Other 510(k) Records For Product Code KWP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015-07-29 |
| K150753 | OASYS System | Stryker Corporation | 2015-06-09 |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | 2015-06-04 |
| K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015-04-29 |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 |
| K142253 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-23 |
| K143249 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 |
| K142741 | OASYS System | Stryker Corporation | 2015-01-15 |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m | 2014-12-22 |
| K140734 | NEXTGEN ALTIUS OCT SYSTEM | Ebi, LLC | 2014-12-15 |
| K142460 | EXPEDIUM Spine System/Synapse System | Johnson and Johnson | 2014-10-01 |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | Synthes USA Products, LLC | 2014-09-25 |
| K141284 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2014-07-23 |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014-06-02 |
Legacy Summary#
summary
FDA Review#
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