510(k) K030252
- Device
- ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
- Applicant
- ORTHOTEC, L.L.C.
- 510(k) number
- K030252
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-21
- Date received
- 2003-01-24
- Regulation
- 888.3050
- Classification name
- Appliance, Fixation, Spinal Interlaminal
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK BERTRANOU
- Address
- 9595 Wilshire Blvd., Suite 502 California CA US 90212 90212
FDA Registration Numbers#
- 2183946
- 3006272282
- 3010440433
- 3025603301
- 1000200989
- 3015383864
- 3010365473
- 3012711663
- 1226425
- 3010370554
- 9617297
- 3012491394
- 3004024955
- 1223434
- 3012329926
- 3016084569
- 3022159082
- 9610612
- 1835831
- 3009169996
- 3014252644
- 3006639944
- 1000517406
- 3015179588
- 3005076207
- 3009380063
- 3013422236
- 3013514648
- 3006791286
- 3007353762
- 1000432246
- 3010047454
- 2028632
- 3007923096
- 3014725904
- 3010143171
- 3004188066
- 3011015572
- 1833824
- 3036756245
- 1226544
- 3003477135
- 2032098
- 3009050824
- 2133687
- 1528646
- 3016496998
- 3005819474
- 3007922509
- 3011221483
- 9611610
- 3019767615
- 1645151
- 3003525643
- 3008455034
- 3005596514
- 3012131184
- 1000461041
- 2032112
- 9611390
- 3007728266
- 3008992889
- 1835572
- 3000170817
- 3015941638
- 3008868758
- 3019837678
- 3009051471
- 1056553
- 3003120897
- 1526534
- 3003541440
- 3003639920
- 1835251
- 3002976036
- 3005426761
- 9612420
- 1030489
- 3014273501
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 |
| K133288 | CASPIAN OCT SPINAL SYSTEM | K2m, Inc. | 2014-07-01 |
Legacy Summary#
summary
FDA Review#
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