K233223 is an FDA 510(k) clearance for the OGmend® Implant Enhancement System. This device is classified as a Screw Sleeve Bone Fixation Device, Spine (Class II - Special Controls, product code QVI).
Submitted by Woven Orthopedic Technologies (Manchester, US). The FDA issued a Cleared decision on October 26, 2023, 28 days after receiving the submission on September 28, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3043. A Spinal Screw Sleeve Bone Fixation Device Is Intended To Be Implanted In Conjunction With A Non-resorbable, Metallic Bone Screw Where The Screw Has Lost Purchase Due To Loosening, Backout, Or Breakage. The Device Fits Between The Screw Threads And Surrounding Bone, And Provides Increased Surface Area To Create An Interference Fit To Restore Stability Of The Implant Construct..
| 510(k) Number | K233223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | October 26, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QVI - Screw Sleeve Bone Fixation Device, Spine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3043 |
| Definition | A Spinal Screw Sleeve Bone Fixation Device Is Intended To Be Implanted In Conjunction With A Non-resorbable, Metallic Bone Screw Where The Screw Has Lost Purchase Due To Loosening, Backout, Or Breakage. The Device Fits Between The Screw Threads And Surrounding Bone, And Provides Increased Surface Area To Create An Interference Fit To Restore Stability Of The Implant Construct. |