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#
- 3003935342
- 3012131184
- 1223434
- 3007604895
- 3011221483
- 1722511
- 3010160527
- 3009882675
- 1835572
- 3011170410
- 3008455034
- 3014938863
- 8020776
- 3006017180
- 3009173317
- 3030412764
- 3023265483
- 3011577940
- 3007993775
- 3015941638
- 9614209
- 3007675554
- 3006378738
- 3007539489
- 3005596514
- 3010123206
- 3010370500
- 3008992889
- 3013422238
- 3006460162
- 3003639920
- 3004719693
- 3013055499
- 2183449
- 3010866843
- 3013011598
- 3007441485
- 3012329926
- 3010041430
- 3011874600
- 3015831087
- 3013548554
- 3006563559
- 3002976036
- 2134470
- 9616062
- 1720929
- 1526534
- 1000493591
- 9611813
- 3007887127
- 3019837678
- 1066368
- 1828288
- 9617297
- 3009050824
- 1834331
- 1056553
- 3009888740
- 1000200989
- 3014273501
- 9681642
- 3014725904
- 3008110533
- 3011796723
- 3011277306
- 3004638532
- 1225838
- 3008812560
- 3008850074
- 1935627
- 3004499989
- 3008285983
- 3009959868
- 3016438694
- 3033509898
- 3010370880
- 3012599928
- 3007344102
- 3004635447
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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