510(k) K042789
- Device
- VERTEX RECONSTRUCTION SYSTEM
- Applicant
- MEDTRONIC SOFAMOR DANEK
- 510(k) number
- K042789
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-21
- Date received
- 2004-10-06
- 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
- RICHARD TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3037407500
- 3010041430
- 3006846753
- 3014268622
- 1057425
- 3009971621
- 3006110997
- 3012429289
- 3014725904
- 1030489
- 3015440604
- 3007014520
- 3002976036
- 1000493591
- 1835251
- 1834331
- 3004638532
- 3015869121
- 2183946
- 9617297
- 1835444
- 1000461041
- 3005706667
- 2031910
- 3016261131
- 1645151
- 3013491327
- 1424434
- 3013422238
- 3034676720
- 3009217531
- 3003935342
- 3010365473
- 3011221483
- 3009169872
- 1833920
- 3005562917
- 3033509898
- 3009790163
- 3000170817
- 9611390
- 2531477
- 3025603301
- 3009973699
- 3003541440
- 3002807561
- 3010370554
- 1833986
- 3015869493
- 9610612
- 3008868758
- 3012329926
- 3010665091
- 1824313
- 1835296
- 3016050940
- 3009380063
- 3010097171
- 1530390
- 3003639920
- 3020282716
- 3013011598
- 2032521
- 1935627
- 3007993775
- 3012447612
- 8043792
- 2183449
- 1649518
- 2133928
- 9612277
- 3023852420
- 3009504230
- 3009941480
- 3030412764
- 3009882675
- 3027807601
- 3031240334
- 1000200989
- 3003526896
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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