FDA 510(k)

CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5

K-Number: K112876 · 2011-12-15

Decision Date2011-12-15

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2011-12-15 under 510(k) number K112876. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5?

CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 is a medical device that received FDA 510(k) clearance on 2011-12-15. The listed applicant is Cayenne Medical, Inc.. The 510(k) number is K112876.

When did CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 receive FDA 510(k) clearance?

CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 received FDA 510(k) clearance on 2011-12-15, under 510(k) number K112876.

Who is the listed applicant for CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5?

The FDA 510(k) record lists Cayenne Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5?

The FDA product code for CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 is MBI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cayenne Medical, Inc. as applicant

K180274Ventix Link Knotless Anchor with Inserter K172186BioWick X Implant with Driver K161033AFX™ Femoral Implant With Inserter K132867SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM K131325QUATTRO GL SUTURE ANCHOR K122314QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY

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Related Devices (Code: MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.