K073439 is an FDA 510(k) clearance for the TRANSITION STABILIZATION SYSTEM. This device is classified as a Posterior Metal/polymer Spinal System, Fusion (Class II - Special Controls, product code NQP).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on February 20, 2009, 441 days after receiving the submission on December 7, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. This Device Is A Posterior Spinal System That Contains Polymer And Metal Components. This Spinal System Is To Be Used With Bone Graft And Is An Adjunct To Fusion In The Treatment Of Acute And Chronic Instabilities Or Deformities Of The Thoracic, Lumbar, And Sacral Spine..
| 510(k) Number | K073439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 07, 2007 |
| Decision Date | February 20, 2009 |
| Days to Decision | 441 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NQP — Posterior Metal/polymer Spinal System, Fusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | This Device Is A Posterior Spinal System That Contains Polymer And Metal Components. This Spinal System Is To Be Used With Bone Graft And Is An Adjunct To Fusion In The Treatment Of Acute And Chronic Instabilities Or Deformities Of The Thoracic, Lumbar, And Sacral Spine. |