510(k) K013887
- Device
- BACFIX SPINAL FIXATION SYSTEM
- Applicant
- SPINAL CONCEPTS, INC.
- 510(k) number
- K013887
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-12
- Date received
- 2001-11-23
- 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
- DAVID M HOPPER
- Address
- 12012 Technology Blvd., #100 Austin TX US 78727 78727
FDA Registration Numbers#
- 3010057495
- 3010370500
- 3006791286
- 1528646
- 1835831
- 1834379
- 3025603301
- 3000203391
- 3011181154
- 3015398319
- 3007887127
- 3006082533
- 3007353762
- 3009882675
- 1833986
- 3013011598
- 3010120135
- 2530808
- 3012491394
- 9611813
- 9612277
- 3018210489
- 3009973505
- 3009049161
- 3007345964
- 1424263
- 9616944
- 3008102042
- 3014252644
- 3004774118
- 2648623
- 3009169996
- 3036756245
- 1530390
- 2032830
- 3016438694
- 1643817
- 3031240334
- 3008285983
- 3004941535
- 1319660
- 3006404071
- 3010041993
- 3014273424
- 3004024955
- 3002808227
- 3009998573
- 3006639944
- 3004788213
- 1057425
- 3009165919
- 1220477
- 3015860552
- 2032112
- 9617544
- 1224360
- 2032098
- 3013055499
- 2183946
- 3007728266
- 3011796723
- 1834331
- 3010123256
- 3005226664
- 3009149199
- 9681642
- 1835572
- 3008749819
- 3006272282
- 9611390
- 9616062
- 3023852420
- 3011513267
- 3015869121
- 3009962553
- 3009144915
- 3009173317
- 3004188066
- 3012863589
- 3006783837
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