510(k) K083077
- Device
- ULC SPINAL PEDICLE SCREW SYSTEM
- Applicant
- OTIS BIOTECH CO., LTD
- 510(k) number
- K083077
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-26
- Date received
- 2008-10-16
- Regulation
- 888.3070
- Classification name
- Orthosis, Spondylolisthesis Spinal Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JISUK YOO
- Address
- 514, 2-Ba Block, Jungwang-Dong Sihma Industrial Complex Siheung-Si, Gyounggi-Do KR 429-450 429-450
FDA Registration Numbers#
- 3007353762
- 3009380063
- 3009165919
- 3010663372
- 1424434
- 3013548554
- 3010365473
- 3025603301
- 1528646
- 3004748528
- 3009217531
- 3016443334
- 3005497913
- 3016496998
- 3034676720
- 3014725904
- 1045254
- 3014655115
- 2032521
- 3005874553
- 3006128100
- 3002807561
- 3009468807
- 3009169996
- 3006217744
- 9612420
- 3009998573
- 9611827
- 3011513267
- 1720929
- 1319429
- 3007887127
- 3007728266
- 1835251
- 3010120339
- 3005325790
- 1835444
- 3000270450
- 3010041499
- 3010178296
- 3010863450
- 3009049161
- 1835572
- 1450662
- 1530390
- 3017036472
- 3002976036
- 3006272282
- 3010047454
- 2647346
- 3003526896
- 3020282716
- 3003541440
- 3009106092
- 8043792
- 3003935342
- 3008868758
- 3010049501
- 9616944
- 3006356043
- 3011390763
- 3010197239
- 1935627
- 3009504230
- 1319660
- 3009888740
- 3018210489
- 1000200989
- 3006984710
- 3010370500
- 3015876273
- 3010509633
- 3016438694
- 3006639944
- 3011489618
- 3008285983
- 2029275
- 1223434
- 3005083075
- 1834331
Source Documents#
Other 510(k) Records For Product Code MNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016-12-02 |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 |
| K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016-08-30 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| K153404 | Zavation Spinal System | Zavation, LLC | 2016-04-21 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016-03-02 |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| K151695 | Romeo posterior osteosynthesis system | Spineart | 2015-09-10 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015-06-26 |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015-04-29 |
| K142798 | PASS LP Spinal System | Medicrea International SA | 2015-03-25 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015-02-25 |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 |
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