510(k) K132122
- Device
- KESTREL POSTERIOR CERVICAL SPINE SYSTEM
- Applicant
- OMNI SURGICAL LLC DBA SPINE360
- 510(k) number
- K132122
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-01-22
- Date received
- 2013-07-10
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- DAVE LAMB
- Address
- 5000 Plz. On The Lake, Suite 305 Austin TX US 78746 78746
FDA Registration Numbers
- 1450662
- 3004464325
- 3014252644
- 2031917
- 3001239363
- 3023852420
- 1834331
- 3003541440
- 1833824
- 2032521
- 3009504230
- 3000170817
- 3014268622
- 1045254
- 3012429289
- 9612277
- 3010863450
- 3019767615
- 3006128100
- 3019837678
- 1225838
- 1030489
- 3004719693
- 1649379
- 2183449
- 3004024955
- 3012120772
- 3010365473
- 3009887475
- 3023138345
- 1221053
- 3010047454
- 3009973505
- 3009554293
- 3010287685
- 2087234
- 2032112
- 3012447612
- 3012599928
- 9616062
- 9611827
- 3011513267
- 1530390
- 2531195
- 3006017180
- 1835296
- 3007887127
- 2029275
- 3008992889
- 3004893332
- 1833986
- 1528646
- 1722511
- 3011181154
- 3005226664
- 3016084569
- 3011277306
- 3003526896
- 3010370500
- 3004788213
- 3010120148
- 3009144915
- 8043792
- 3015383864
- 3007485169
- 1836357
- 3007014520
- 3018094310
- 3013111980
- 1423662
- 2031910
- 3009540749
- 3006639944
- 3010440433
- 1000461041
- 1835831
- 2183946
- 2032098
- 3000203391
- 3010197224
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 |
| K143249 | 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 |
| K133288 | CASPIAN OCT SPINAL SYSTEM | K2m, Inc. | 2014-07-01 |
Legacy Summary
summary
FDA Review
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