510(k) K120998
- Device
- SOLSTICE CROSS CONNECTOR
- Applicant
- LIFE SPINE
- 510(k) number
- K120998
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-10-01
- Date received
- 2012-04-02
- 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
- RANDY LEWIS
- Address
- 2401 W. Hassell Rd. Suite 1535 Hoffman Estates IL US 60169 60169
FDA Registration Numbers#
- 3003541440
- 1834379
- 3004142400
- 9612420
- 3015212339
- 3012599928
- 1720929
- 3017565094
- 1000200989
- 1649379
- 3007353762
- 3005031160
- 3013111980
- 1530390
- 3006783837
- 2032521
- 3012120772
- 3010370500
- 3012711663
- 3010123256
- 3008526708
- 3004717358
- 3010663372
- 3009631939
- 2530808
- 3005180920
- 3015399803
- 2648623
- 3031240334
- 3043543260
- 3007922509
- 3010462278
- 3030412764
- 3010120326
- 3010049501
- 3009149199
- 3010032903
- 1221053
- 2531195
- 3010123206
- 1645151
- 3011796723
- 2133928
- 1835251
- 3005426761
- 3010365473
- 3010160527
- 2027467
- 3025603301
- 3000170817
- 3009217531
- 9615021
- 3016438694
- 1221763
- 3008534770
- 1835831
- 3006017180
- 3010287685
- 3006272282
- 3010863450
- 3015440604
- 3009732568
- 2031910
- 1226425
- 3007923096
- 3013514648
- 3008198024
- 3014252644
- 3006378738
- 8010944
- 1835572
- 1220477
- 3010097171
- 3005874553
- 3013422238
- 3010162973
- 1836357
- 1450662
- 2133687
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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