510(k) K023797
- Device
- LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
- Applicant
- MEDTRONIC SOFAMOR DANEK
- 510(k) number
- K023797
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-13
- Date received
- 2002-11-14
- 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 W TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3009173317
- 3014725904
- 3003541440
- 3005562917
- 3009973699
- 3010041430
- 1000200989
- 3009959868
- 1530390
- 3006783837
- 3007887127
- 3012495575
- 3015179588
- 3004142400
- 3000170817
- 1221763
- 3015398319
- 3006215390
- 3022159082
- 1319429
- 1528646
- 3013111980
- 3004788213
- 2531477
- 3004153896
- 1526439
- 3011187779
- 3014273424
- 3013491327
- 3010032903
- 1043653
- 2027467
- 1720929
- 3005739886
- 3011181154
- 3008534770
- 3012491394
- 3005874553
- 1835831
- 3037407500
- 1828464
- 3004774118
- 3007125392
- 9617544
- 2028632
- 9681465
- 1835444
- 3014268622
- 3010863450
- 3023265483
- 2530808
- 1000432246
- 3006356043
- 3015941638
- 3010143171
- 3013548554
- 3015869493
- 3007539489
- 3001239363
- 3005076207
- 1836357
- 3010462278
- 3011796723
- 3013422238
- 2133687
- 1833920
- 3018094310
- 1643817
- 1824313
- 3008812560
- 3010365473
- 1526534
- 3009973505
- 3014938863
- 3013422236
- 3010665091
- 1935627
- 3005061536
- 3019767615
- 3008583793
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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