510(k) K101183
- Device
- MODIFICATION TO: OASYS SYSTEM
- Applicant
- STRYKER SPINE
- 510(k) number
- K101183
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-11-09
- Date received
- 2010-04-28
- 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
- PAULINE SHAND
- Address
- 2 Pearl Ct. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 9617297
- 3007604895
- 1226544
- 3023265483
- 3007993775
- 3007485169
- 3006846753
- 3011221483
- 3010866843
- 1000493591
- 3009554293
- 3005819474
- 3006563559
- 3015869121
- 3043543260
- 3010370880
- 3010646402
- 2531477
- 3013514648
- 3036756245
- 3034676720
- 1828288
- 3015941638
- 3024999441
- 2133687
- 3008526708
- 3006217744
- 3016443334
- 3010120326
- 3004893332
- 2531195
- 2530808
- 2028632
- 3010041993
- 3010120135
- 3008110533
- 3009169872
- 3010665091
- 2032112
- 3017565094
- 3031240334
- 3014252644
- 1526439
- 1527105
- 3012495575
- 1221763
- 3004774118
- 2029275
- 9681465
- 3010041430
- 1832228
- 3009504230
- 1424263
- 3000170817
- 3007353762
- 3005562917
- 3016261131
- 3015383864
- 3003935342
- 3009173317
- 3013111980
- 3012711663
- 2032093
- 3025457095
- 3015179588
- 2647346
- 3020282716
- 9610612
- 1000432246
- 3008868758
- 1822565
- 8020776
- 8043792
- 1835572
- 3005180920
- 3005706667
- 1225838
- 3012491394
- 2134285
- 3009887475
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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