OsteoCoil GT Active Compression System— 510(k) K260106
Substantially EquivalentFlower Orthopedics Corporation DBA Conventus Flower Orthoped
FDA 510(k) clearance K260106 for OsteoCoil GT Active Compression System, Substantially Equivalent on 2026-08-24. Applicant: Flower Orthopedics Corporation DBA Conventus Flower Orthoped. Device class: 2.
Summary
The OsteoCoil GT Active Compression System is filed under product code HWC, bone fixation screws. The applicant is Flower Orthopedics Corporation, listed with a DBA name that is cut off in the record.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Horsham, Pennsylvania. FDA found it substantially equivalent 222 calendar days after receipt (January 14 to August 24, 2026).
Clearance details
- Applicant
- Flower Orthopedics Corporation DBA Conventus Flower Orthoped
- Product code
- Product code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Horsham, PA, US
Recent devices under product code HWC
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.