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510(k) K040827 · MAI Fastener, Fixation, Biodegradable, Soft Tissue

PANALOK LOOP ANCHOR

Applicant	Depuy Mitek, A Johnson & Johnson Company, Norwood MA, US
Decision	Substantially Equivalent, Apr 30, 2004
Received	Mar 30, 2004
Type	Special
FDA record	Open on fda.gov

Recalls that name K040827

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
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	MAI	None listed
Mar 6, 2012	DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation. Terminated	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 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

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.