Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
K-Number: K193295 · 2020-01-23
ApplicantParcus Medical, LLC
Decision Date2020-01-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2020-01-23 under approval number K193295. 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 Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor?
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Parcus Medical, LLC. The 510(k) number is K193295.
When was Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor approved by the FDA?
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor received FDA 510(k) clearance on 2020-01-23, under approval number K193295.
What company makes Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor?
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor is manufactured by Parcus Medical, LLC.
What is the FDA product code for Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor?
The FDA product code for Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor is MBI.
Related Clinical Trials
Other Devices by Parcus Medical, LLC
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.