Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ActiFlip

K-Number: K212739 · 2021-10-06

ApplicantParcus Medical, LLC
Decision Date2021-10-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ActiFlip is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2021-10-06 under approval number K212739. 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 ActiFlip?

ActiFlip is a medical device that received FDA 510(k) clearance on 2021-10-06. It is manufactured by Parcus Medical, LLC. The 510(k) number is K212739.

When was ActiFlip approved by the FDA?

ActiFlip received FDA 510(k) clearance on 2021-10-06, under approval number K212739.

What company makes ActiFlip?

ActiFlip is manufactured by Parcus Medical, LLC.

What is the FDA product code for ActiFlip?

The FDA product code for ActiFlip is MBI.

Other Devices by Parcus Medical, LLC

K162198GFS Ultimate K192964Parcus Synd-EZ SS K192824Parcus Knotless AP Suture Anchors K191783Parcus Synd-EZ Ti K190375Parcus ATLAS K183501Parcus Twist AP Suture Anchors

View all 15 devices →

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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.

↑