Synd EZ

GUDID 00816342025003

Synd-EZ Solo Ti

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342025003
NIH Device Record Key78e823bd-6f16-446c-8a3a-139b926e0adc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynd EZ
Version Model Number11225
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100816342025003 [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

Devices Manufactured by PARCUS MEDICAL LLC

00816342022491 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025447 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025454 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025461 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025478 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025485 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025492 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025508 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
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