Product code OSH
- Device name
- Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3070
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153446 | OLYMPIC Posterior Spinal Fixation System | Astura Medical | 2016-04-08 |
| K140276 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2014-03-13 |
| K132574 | PASS LP SPINAL SYSTEM | Medicrea International | 2013-11-08 |
| K132303 | IMPLANET SPINE SYSTEM | Implanet, S.A. | 2013-10-10 |
| K132575 | PASS LP SPINAL SYSTEM | Medicrea International | 2013-10-03 |
| K131802 | EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM | Depuy Spine, A Johnson & Johnson Company | 2013-09-12 |
| K131615 | POLARIS SPINAL SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2013-09-04 |
| K131784 | RANGE SPINAL SYSTEM | K2m, Inc. | 2013-08-30 |
| K131321 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA | 2013-06-05 |
| K124058 | CREO STABILIZATION SYSTEM | Globus Medical, Inc. | 2013-05-13 |
| K131030 | RANGE SPINAL SYSTEM | K2m, Inc. | 2013-05-09 |
| K122877 | RANGE SPINAL SYSTEM, SMALL STATURE | K2m, Inc. | 2013-05-08 |
| K130655 | RESPONSE SPINE SYSTEM | OrthoPediatrics Corp. | 2013-05-08 |
| K130330 | RANGE SPINAL SYSTEM | K2m, Inc. | 2013-05-02 |
| K123412 | RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS | K2m, Inc. | 2013-02-13 |
| K123138 | PASS LP SPINAL SYSTEM | Medicrea International | 2013-02-05 |
| K121630 | RANGE SPINAL SYSTEM | K2m, Inc. | 2012-09-11 |
| K121250 | OP SPINE SYSTEM | OrthoPediatrics Corp. | 2012-06-19 |
| K120291 | OP SPINE SYSTEM | OrthoPediatrics Corp. | 2012-04-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888857001435 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857001718 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857001701 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857001695 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857001688 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857001657 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857001428 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857001459 | DENALI® MI Spinal System | VB Spine LLC | 2018-11-05 |
| 10888857002111 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857002098 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857002135 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857002159 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857002173 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857002074 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857002050 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857002036 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001992 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001978 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001947 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001923 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001848 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001824 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001787 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001763 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001725 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001640 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001619 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001589 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001527 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |
| 10888857001497 | DENALI® MI Spinal System | VB Spine LLC | 2015-09-24 |