510(k) K140645
- Device
- GIBRALT ROD-TO-ROD CROSS CONNECTORS
- Applicant
- EXACTECH SARASOTA
- 510(k) number
- K140645
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-11
- Date received
- 2014-03-13
- 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 HUGHES
- Address
- 7455 16th St. E. Suite 105 Sarasota FL US 34243 34243
FDA Registration Numbers#
- 3010097171
- 3001239363
- 1424263
- 3023265483
- 3011577940
- 3010440433
- 3007014520
- 1000493591
- 3010178296
- 9614209
- 3012495575
- 3016261131
- 3006563559
- 2532027
- 3009144915
- 1833920
- 3010057495
- 1835296
- 3011187779
- 3009217531
- 8020776
- 3012329926
- 3002976036
- 1835572
- 3009509485
- 3005819474
- 1000517406
- 3009887475
- 3007353762
- 3009732568
- 3009051471
- 3009504230
- 1833986
- 3010049501
- 3009888740
- 1531174
- 3010646402
- 3010462278
- 3011015572
- 3008455034
- 1223434
- 3006639944
- 3008110533
- 1720929
- 3010120339
- 3017435639
- 9611813
- 3010663372
- 1828288
- 3009790163
- 3007766698
- 3008526708
- 2648623
- 3034676720
- 8043792
- 1226544
- 9612277
- 3005497913
- 1224360
- 3012131184
- 3015399803
- 3004464325
- 3003639920
- 3010370554
- 1226425
- 3010120135
- 9681642
- 3031240334
- 3011874600
- 3015179588
- 3014725904
- 9617544
- 3000170817
- 3012491394
- 3016443334
- 3000270450
- 1526439
- 3020282716
- 3007923096
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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