Depuy Mitek, A Johnson & Johnson Company FDA Record
Depuy Mitek, A Johnson & Johnson Company has 0 FDA recalls, 0 inspections, 62 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Depuy Mitek, A Johnson & Johnson Company" is on file.
- Latest 510(k)
- Oct 6, 2015
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 62 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK… | Oct 6, 2015 |
| K143660 | Milagro / Milagro Advance Interference Screw | May 21, 2015 |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2… | Oct 24, 2014 |
| K140896 | VAPR ARCTIC SUCTION ELECTRODE | Aug 5, 2014 |
| K140643 | GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY | Jul 8, 2014 |
| K140324 | RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL | Jul 7, 2014 |
| K141259 | GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH… | Jun 10, 2014 |
| K133794 | 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR… | Feb 4, 2014 |
| K132241 | GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK… | Nov 5, 2013 |
| K130814 | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | Aug 1, 2013 |
| K131974 | HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) | Jul 25, 2013 |
| K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM… | Jul 22, 2013 |
| K130912 | OMNICUT RESECTION BLADE | Jun 14, 2013 |
| K130917 | HEALIX ADVANCE KNOTLESS BR ANCHOR | May 24, 2013 |
| K130539 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) | May 21, 2013 |
| K130105 | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM | May 17, 2013 |
| K130169 | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE | May 1, 2013 |
| K123362 | MILAGRO ADVANCE INTERFERENCE SCREW | Feb 1, 2013 |
| K122869 | MILAGRO INTERFERENCE SCREWS | Dec 13, 2012 |
| K122425 | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS… | Nov 5, 2012 |
Depuy Mitek, A Johnson & Johnson Company and the FDA: common questions
Has Depuy Mitek, A Johnson & Johnson Company received an FDA warning letter?
No FDA warning letter addressed to the name "Depuy Mitek, A Johnson & Johnson Company" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Depuy Mitek, A Johnson & Johnson Company received an FDA Form 483?
FDA has not published a Form 483 for "Depuy Mitek, A Johnson & Johnson Company" in its reading room. FDA publishes some Form 483s, not all of them.
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