510(k) K132280
- Device
- ALTUS SPINE PEDICLE SCREW SYSTEM
- Applicant
- ALTUS PARTNERS
- 510(k) number
- K132280
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-10-31
- Date received
- 2013-07-23
- Regulation
- 888.3070
- Classification name
- Orthosis, Spinal Pedicle Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- CLAUDIA HILL
- Address
- 5129 W. Chester Pike Newtown Square PA US 19073 19073
FDA Registration Numbers
- 1450662
- 3004464325
- 3014252644
- 2031917
- 3001239363
- 2183744
- 3023852420
- 1834331
- 3003541440
- 3009962553
- 3002807112
- 2032521
- 2031093
- 3009504230
- 3000170817
- 1319660
- 3008754074
- 1045254
- 9612277
- 3010863450
- 3019767615
- 3006128100
- 3019837678
- 1225838
- 1030489
- 3004719693
- 1649379
- 2183449
- 3004024955
- 3012120772
- 3010365473
- 3005083075
- 3009887475
- 3023138345
- 1221053
- 3010047454
- 3009973505
- 3009554293
- 3010287685
- 2087234
- 9614841
- 2032112
- 3012447612
- 9616062
- 9611827
- 3011513267
- 1530390
- 2531195
- 3006017180
- 1835296
- 3007887127
- 2029275
- 3008992889
- 3010531060
- 3004893332
- 1833986
- 1528646
- 1722511
- 3011181154
- 3005226664
- 3009165919
- 3011277306
- 3003526896
- 3015967359
- 3010370500
- 3004788213
- 3010120148
- 3009144915
- 8043792
- 3011765094
- 3007485169
- 1836357
- 3007014520
- 3018094310
- 1423662
- 3004176895
- 3006404071
- 3006639944
- 3010440433
- 3010197239
Source Documents
Other 510(k) Records For Product Code MNI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016-08-22 |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016-06-29 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | 2016-04-04 |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015-12-11 |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 |
| K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 |
Legacy Summary
summary
FDA Review
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