510(k) K070925 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
| Applicant | Depuy Mitek, A Johnson & Johnson Company, Raynham MA, US |
| Decision | Substantially Equivalent, May 2, 2007 |
| Received | Apr 3, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2023 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization
Model Number: 212724 Open, Classified |
MAI | None listed |
| Jun 2, 2023 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization
Model Number: 212725 Open, Classified |
MAI | None listed |
| Jun 2, 2023 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization
Model Number: 212726 Open, Classified |
MAI | None listed |
| Jun 2, 2023 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization
Model Number: 212722 Open, Classified |
MAI | None listed |
| Jun 2, 2023 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization
Model Number: 212723 Open, Classified |
MAI | None listed |
| Nov 30, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek Panalock Loop, Lupine Anchor
Catalog #210704
The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Terminated |
MAI | None listed |
| Nov 30, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek Lupine Loop Plus w/ Orthocord
Catalog #210708
The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilizat Terminated |
MAI | None listed |
| Nov 30, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek Lupine Loop Plus w/ Orthocord DS
Catalog #210709
The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliz Terminated |
MAI | None listed |
| Nov 30, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek Lupine Loop Rapide w/ Orthocord
Catalog #210711
The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilizati Terminated |
MAI | None listed |
| Nov 30, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek Panalock Loop w/ Orthocord
Catalog #222980
The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Terminated |
MAI | None listed |
| Sep 17, 2008 | DePuy Mitek, Inc., a Johnson & Johnson Co. Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor Terminated |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.