510(k) K121877
- Device
- GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
- Applicant
- EXACTECH, INC.
- 510(k) number
- K121877
- Product code
- KWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-02-12
- Date received
- 2012-06-28
- Regulation
- 888.3050
- Classification name
- Appliance, Fixation, Spinal Interlaminal
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VLADISLAVA ZAITSEVA
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3009051471
- 3004499989
- 1526534
- 3010197224
- 9681465
- 9614209
- 3010120339
- 3005641619
- 2183449
- 9611390
- 2032093
- 3004635447
- 2532027
- 3008114965
- 3010160527
- 3012429289
- 3010866843
- 3009704301
- 3017528621
- 9617297
- 2530808
- 3019837678
- 9611610
- 3011181154
- 3013011598
- 1828288
- 3010123206
- 3009144915
- 3004142400
- 3016084569
- 3023852420
- 3010120148
- 1030489
- 3009971621
- 3017565094
- 3010041993
- 3010365473
- 3009173317
- 3013422238
- 3009887475
- 3006563559
- 3010120104
- 3005325790
- 3023138345
- 3009631939
- 3006846753
- 3009959868
- 1043653
- 1935627
- 3010162973
- 1530530
- 1834331
- 3006356043
- 3036756245
- 3009790163
- 3010057495
- 3002807561
- 1531174
- 3008110533
- 3010462278
- 1833824
- 1528646
- 2133928
- 3000270450
- 3008583793
- 2029275
- 1835444
- 1526439
- 3005497913
- 3009973699
- 3014268622
- 2032098
- 3008455034
- 1045254
- 8010944
- 1828464
- 3003541440
- 3004717358
- 3005596514
- 3011015572
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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