Twist PEEK Suture Anchor

GUDID 00816342024365

Twist 5.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342024365
NIH Device Record Key10844643-2a43-40ef-b5a5-d2f9375e9bcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwist PEEK Suture Anchor
Version Model Number11286
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342024365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-30

On-Brand Devices [Twist PEEK Suture Anchor]

00816342021470Twist 5.5mm PEEK Suture Anchor
00816342023368Twist 6.5mm PEEK Suture Anchor
00816342023351Twist 6.5mm PEEK Suture Anchor
00816342023344Twist 5.5mm PEEK Suture Anchor
00816342023337Twist 5.5mm PEEK Suture Anchor
00816342023320Twist 4.5mm PEEK Suture Anchor
00816342023313Twist 4.5mm PEEK Suture Anchor
00816342025218Twist 5.5mm PEEK SST Suture Anchor
00816342025201Twist 5.5mm PEEK SST Suture Anchor
00816342025195Twist 4.5mm PEEK SST Suture Anchor
00816342025188Twist 4.5mm PEEK SST Suture Anchor
00816342024365Twist 5.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
00816342024358Twist 5.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
00816342024341Twist 4.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
00816342024334Twist 4.5mm PEEK Suture Anchor, w/2 1.6mm Suture Tape
008163420241746.5 x 12.6mm, Twist, screw-in, suture anchor, w/2, 1.6mm suture tapes (wht/blu & wht/blk), PEEK
008163420239485.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)
008163420239314.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.