X-Twist PEEK Suture Anchor
K-Number: K221135 · 2022-05-19
ApplicantParcus Medical, LLC
Decision Date2022-05-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
X-Twist PEEK Suture Anchor is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2022-05-19 under approval number K221135. 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 X-Twist PEEK Suture Anchor?
X-Twist PEEK Suture Anchor is a medical device that received FDA 510(k) clearance on 2022-05-19. It is manufactured by Parcus Medical, LLC. The 510(k) number is K221135.
When was X-Twist PEEK Suture Anchor approved by the FDA?
X-Twist PEEK Suture Anchor received FDA 510(k) clearance on 2022-05-19, under approval number K221135.
What company makes X-Twist PEEK Suture Anchor?
X-Twist PEEK Suture Anchor is manufactured by Parcus Medical, LLC.
What is the FDA product code for X-Twist PEEK Suture Anchor?
The FDA product code for X-Twist PEEK Suture Anchor is MBI.
Other Devices by Parcus Medical, LLC
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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.