ICONN Square 2.5MM Suture Anchor

GUDID 00860419000226

ICONN ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00860419000226
NIH Device Record Key240e5208-c397-401a-800d-dc3ff6f12c10
Commercial Distribution StatusIn Commercial Distribution
Brand NameICONN Square 2.5MM Suture Anchor
Version Model Number125000
Company DUNS055774745
Company NameICONN ORTHOPEDICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860419000226 [Primary]

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00860419000226]

Radiation Sterilization


[00860419000226]

Radiation Sterilization


[00860419000226]

Radiation Sterilization


[00860419000226]

Radiation Sterilization


[00860419000226]

Radiation Sterilization


[00860419000226]

Radiation Sterilization


[00860419000226]

Radiation Sterilization


[00860419000226]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-25
Device Publish Date2025-09-17

Devices Manufactured by ICONN ORTHOPEDICS LLC

00860006776015 - ICONN Revolution Knotless Suture Anchor2025-09-25
00860006776022 - ICONN Square Suture Anchor Knotless2025-09-25
00860419000226 - ICONN Square 2.5MM Suture Anchor2025-09-25
00860419000226 - ICONN Square 2.5MM Suture Anchor2025-09-25
00860419000257 - ICONN Answer II 4.75MM Suture Anchor2025-09-25
00860419000264 - ICONN Answer II 5.5MM Suture Anchor2025-09-25
00860419000271 - ICONN Answer II 6.5MM Suture Anchor2025-09-25
00860419000295 - ICONN Revolution Knotless Suture Anchor2025-09-25
00860419000202 - ICONN Answer 4.75MM Suture Anchor2019-03-21 ICONN Answer 4.75MM Suture Anchor

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