3.5 X 15.5mm Citrefix XPress System

GUDID 00810027270863

Acuitive Technologies, Inc.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable
Primary Device ID00810027270863
NIH Device Record Key88b5d325-fdb4-4822-934c-a396b9153d7f
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5 X 15.5mm Citrefix XPress System
Version Model Number70-810-3515
Company DUNS074645634
Company NameAcuitive Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com
Phone201-661-2680
Emailmpoggie@acuitivetech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810027270863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-25
Device Publish Date2022-07-15

Devices Manufactured by Acuitive Technologies, Inc.

00810027271471 - Citrelock ACL 1.1mm K-Wire2024-03-07
00810027270436 - Citrefix 2.9mm Inserter2023-07-03
00810027270443 - Citrefix 3.5mm Inserter2023-07-03
00810027270450 - Citrefix 4.5mm Inserter2023-07-03
00810027270467 - Citrefix 5.5mm Inserter2023-07-03
00810027270474 - Citrefix 2.9mm Drill2023-07-03
00810027270481 - Citrefix 3.5mm Drill2023-07-03
00810027270498 - Citrefix 4.5mm Drill2023-07-03

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