Cayenne Medical, Inc.
Cayenne Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2018, with 3 FDA device recalls on record.
Top product codes for Cayenne Medical, Inc.
FDA recalls by Cayenne Medical, Inc.
- Z-2571-2018 — Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
- Z-2422-2018 — AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
- Z-2548-2018 — AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cayenne Medical, Inc.
- K180274 — Ventix Link Knotless Anchor with Inserter
- K172186 — BioWick X Implant with Driver
- K161033 — AFX Femoral Implant With Inserter
- K151068 — SureLock W Suture Anchor
- K143473 — Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles
- K143392 — Quattro Bolt Tenodesis Screw
- K132867 — SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM
- K131325 — QUATTRO GL SUTURE ANCHOR
- K122314 — QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
- K122463 — APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
- K121413 — CROSSFIX II MEMISCAL REPAIR DEVICE
- K112814 — CUFFINK
- K112960 — LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE
- K112876 — CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
- K083607 — APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
- K083612 — APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
- K082518 — DUAL NEEDLE SUTURE PASSER SYSTEM
- K073426 — APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM
- K073054 — MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
- K071796 — CAPSEW PLICATION SYSTEM
- K063070 — APERFIX TIBIAL IMPLANT WITH INSERTER
- K062487 — APERFIX FEMORAL IMPLANT WITH INSERTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.