Agile Suture Anchor 285945

GUDID 00811714036335

Agile Suture Anchor, 2.5mm diameter with one #2 HS Fiber Suture

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00811714036335
NIH Device Record Key01538cea-c6f8-4203-81b2-16d950b31c6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAgile Suture Anchor
Version Model Number285945
Catalog Number285945
Company DUNS002745858
Company NameRESPONSIVE 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 Numberfalse
Manufacturing Datetrue
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
GS100811714036335 [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 Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by RESPONSIVE ORTHOPEDICS LLC

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00811714036199 - Superhawk2025-05-22 Superhawk Drill 3.5mm
00811714036205 - Superhawk2025-05-22 Superhawk Cannulated Drill 3.0mm
00811714036212 - Superhawk2025-05-22 Superhawk Drill 3.0mm
00811714036229 - Superhawk2025-05-22 Superhawk Cannulated Drill 3.5mm
00811714036236 - Superhawk2025-05-22 Superhawk Guidewire 150mm Length
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