510(k) K142867
- Device
- Reliance Posterior Cervical-Thoracic System
- Applicant
- Reliance Medical Systems, LLC
- 510(k) number
- K142867
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-29
- Date received
- 2014-10-01
- 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
- Bret M. Berry
- Address
- 545 W 500 S. Suite 100 Bountiful UT US 84010 84010
FDA Registration Numbers#
- 1935627
- 3007728266
- 3006172536
- 3009509485
- 3017565094
- 3008812560
- 1000493591
- 3007993775
- 2031910
- 3005739886
- 3004024955
- 3010365473
- 3010143171
- 1835572
- 3005180920
- 1424434
- 3016438694
- 3005426761
- 3015941638
- 3012764194
- 3023138345
- 3005819474
- 3020282716
- 3010663372
- 3010440433
- 3007922509
- 1223434
- 3007604895
- 3009169996
- 3012711663
- 9611827
- 3010120135
- 3008868758
- 3014252644
- 1828288
- 1834331
- 3007485169
- 3010041499
- 1057425
- 3043543260
- 3009790163
- 3010370880
- 3005677016
- 2133928
- 3016084569
- 1824199
- 3008455034
- 3013111980
- 3005325790
- 3016496998
- 3008114965
- 3009149199
- 3000170817
- 1649518
- 3008534770
- 3010009693
- 3012447612
- 3012120772
- 2648623
- 3009417901
- 9611813
- 3005874553
- 8010944
- 9612420
- 3010120104
- 2183449
- 3025457095
- 3009971621
- 1835444
- 1832228
- 3009973505
- 1835831
- 3023852420
- 3039103971
- 3009540749
- 3006460162
- 3008198024
- 8043792
- 1043653
- 3004719693
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 |
| 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 |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014-06-02 |
Legacy Summary#
summary
FDA Review#
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