GFS - Sterile Screws and Top Hat— 510(k) K253858
Substantially EquivalentT.A.G. Medical Products Corporation, Ltd.
FDA 510(k) clearance K253858 for GFS - Sterile Screws and Top Hat, Substantially Equivalent on 2026-08-05. Applicant: T.A.G. Medical Products Corporation, Ltd.. Device class: 2.
Clearance details
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gaaton Northern, IL
Recent devices under product code HWC
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- K210498 — Betta Link Knotless Implant System
- K202178 — VersaLoop Anchor System
Adverse 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.