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.
Summary
T.A.G. Medical Products filed GFS - Sterile Screws and Top Hat under product code HWC, bone fixation screws. The record doesn't expand GFS or give model numbers.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
The record lists the applicant location as Gaaton Northern, Israel. The decision came 245 calendar days after FDA received it (December 3, 2025 to August 5, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
- 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
- Special
- Location
- Gaaton Northern, IL
Recent devices under product code HWC
view allMore clearances from T.A.G. Medical Products Corporation, Ltd.
view all- K231400 — Bladeless Trocar Artemis Lap Cannula
- K230058 — Bladeless Trocar Artemis Lap Cannula
- K221731 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
- 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.