DEN220030 is an FDA 510(k) submission for the RemeOs™ Screw LAG Solid. This device is classified as a Absorbable Metallic Bone Fixation Fastener (Class II - Special Controls, product code QJD).
Submitted by Bioretec, Ltd. (Tampere, FI). The FDA issued a Not Cleared (DENG) decision on March 29, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3041. An Absorbable Metallic Bone Fixation Fastener Is An Implant, Such As A Bone Screw, Pin, Or Kirschner Wire, Composed Of One Or More Absorbable Metal Or Metal Alloys And Intended To Provide Rigid Bone Fixation Suitable For Osteosynthesis. The Device Is Designed To Fully Absorb After Steosynthesis Is Achieved..
| 510(k) Number | DEN220030 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 04, 2022 |
| Decision Date | March 29, 2023 |
| Days to Decision | 329 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QJD - Absorbable Metallic Bone Fixation Fastener |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3041 |
| Definition | An Absorbable Metallic Bone Fixation Fastener Is An Implant, Such As A Bone Screw, Pin, Or Kirschner Wire, Composed Of One Or More Absorbable Metal Or Metal Alloys And Intended To Provide Rigid Bone Fixation Suitable For Osteosynthesis. The Device Is Designed To Fully Absorb After Steosynthesis Is Achieved. |