510(k) K022623
- Device
- 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
- Applicant
- DEPUY ACROMED
- 510(k) number
- K022623
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-27
- Date received
- 2002-08-07
- 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
- FRANK MAAS
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3004142400
- 3016050940
- 9617544
- 3005677016
- 1531174
- 3005426761
- 3001239363
- 3008868758
- 3015869121
- 1221763
- 9611813
- 1423662
- 3010009693
- 3003541440
- 3014252644
- 3009882675
- 3003526896
- 3011513267
- 3009504230
- 3009169996
- 1000517406
- 3013055499
- 2133687
- 8010944
- 3007728266
- 2032093
- 3014273424
- 1056553
- 3012764194
- 3010370554
- 2031910
- 3013111980
- 3005596514
- 3031240334
- 3006563559
- 1223434
- 3009973699
- 2031917
- 9611610
- 3015941638
- 3017435639
- 2031966
- 1424434
- 1528646
- 1530390
- 1649379
- 1000493591
- 3011874600
- 3015399803
- 1834331
- 3003761012
- 9614209
- 1225838
- 3007539489
- 3009704301
- 2531195
- 3010287685
- 1835572
- 3014725904
- 1529009
- 3009973505
- 9681465
- 3015440604
- 3008850074
- 1043653
- 3009973336
- 3002976036
- 3016261131
- 3010462278
- 3005325790
- 3011221483
- 2029275
- 3010120326
- 3010047454
- 2531477
- 3009049161
- 3006460162
- 1643817
- 3009051471
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases