LATARJET CORTICAL SCREW SET— 510(k) K110763
Substantially EquivalentT.A.G. Medical Products Corporation, Ltd.
FDA 510(k) clearance K110763 for LATARJET CORTICAL SCREW SET, Substantially Equivalent on 2011-04-11. 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
- Somerset, MA, US
Recent devices under product code HWC
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- 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 →
Recalls naming K110763
K-number listed on FDA's recall record- Z-2615-2017 — DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
- Z-2616-2017 — DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
- Z-2617-2017 — DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
- Z-2618-2017 — DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
- Z-2619-2017 — DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110763.
Data sourced from openFDA. This site is unofficial and independent of the FDA.