510(k) K973425
- Device
- THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
- Applicant
- CORIN U.S.A.
- 510(k) number
- K973425
- Product code
- MNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-27
- Date received
- 1997-09-10
- 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
- CRAIG CORRANCE
- Address
- 10500 University Center Dr. Suite 190 Tampa FL US 33612 33612
FDA Registration Numbers#
- 3010097171
- 3001239363
- 1424263
- 1000577893
- 3023265483
- 3011577940
- 3010440433
- 3007014520
- 1000493591
- 3010178296
- 9614209
- 3002808227
- 3016261131
- 3006563559
- 3008102042
- 2532027
- 3009144915
- 1833920
- 3010057495
- 1319660
- 1835296
- 3011187779
- 3009217531
- 8020776
- 3012329926
- 3002976036
- 1835572
- 3009509485
- 3005819474
- 1000517406
- 3009887475
- 3007353762
- 3009732568
- 3009051471
- 3009504230
- 1833986
- 3010049501
- 3009888740
- 1531174
- 3009165919
- 3010462278
- 3008455034
- 1223434
- 3006639944
- 3008110533
- 1720929
- 3010120339
- 3017435639
- 9611813
- 3010663372
- 1828288
- 3008526708
- 2648623
- 8043792
- 1226544
- 9612277
- 3005497913
- 3009106092
- 1224360
- 3015399803
- 3004464325
- 3003639920
- 3010370554
- 9681642
- 3010120135
- 3031240334
- 3011874600
- 3014725904
- 3007738812
- 9617544
- 3000170817
- 3012491394
- 3016443334
- 3000270450
- 1526439
- 3020282716
- 3007923096
- 3009554293
- 3004717358
- 3004638600
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#
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