510(k) K050391
- Device
- PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
- Applicant
- GLOBUS MEDICAL, INC.
- 510(k) number
- K050391
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-07-21
- Date received
- 2005-02-16
- 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
- KELLY J BAKER
- Address
- 303 Schell Ln. Phoenixville PA US 19460 19460
FDA Registration Numbers#
- 3014273424
- 3006563559
- 3010365473
- 3008110533
- 3010041993
- 3014938863
- 3010047454
- 3009049161
- 2032521
- 1043653
- 3009540749
- 3008868758
- 2028632
- 3014725904
- 3006378738
- 3010097171
- 2031966
- 3013111980
- 3007887127
- 3010120148
- 3004024955
- 3020282716
- 3000170817
- 1220477
- 3009888740
- 3003761012
- 3008583793
- 3010160527
- 3017528621
- 3005031160
- 3006272282
- 3009417901
- 3015831087
- 3012120772
- 3027807601
- 1822565
- 3013422236
- 1527105
- 1835831
- 3009169996
- 1935627
- 1649379
- 3009704301
- 1828464
- 2134285
- 9611610
- 1834331
- 3009941480
- 3009217531
- 1030489
- 1424263
- 3015941638
- 3009051471
- 3011874600
- 3007766698
- 9611390
- 3030412764
- 2032098
- 1529009
- 1833920
- 3012764194
- 3004464325
- 3010440433
- 3012131184
- 3010057495
- 3001239363
- 3007675554
- 3007441485
- 3010120135
- 1224360
- 3012329926
- 3007353762
- 3015399803
- 9617297
- 3006128100
- 1066368
- 1056553
- 3010665091
- 3010143171
- 3017435639
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 |
| 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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