SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)— 510(k) K052631
Substantially EquivalentDepuy Mitek, A Johnson & Johnson Company
FDA 510(k) clearance K052631 for SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE), Substantially Equivalent on 2005-10-21. Applicant: Depuy Mitek, A Johnson & Johnson Company. Device class: 2.
Clearance details
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Product code
- Code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Norwood, MA, US
Recent devices under product code JDR
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- K142574 — 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,
- K140896 — VAPR ARCTIC SUCTION ELECTRODE
- K141259 — GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK
- K133794 — 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3
Adverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
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.