Stealth All-Suture Anchor 285949

GUDID 00811714036373

Stealth All-Suture Anchor, with two 1.5mm Suture Tapes

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00811714036373
NIH Device Record Key31446fed-1e03-4ccd-8812-5787214e5ed4
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealth All-Suture Anchor
Version Model Number285949
Catalog Number285949
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
GS100811714036373 [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 Date2025-05-22
Device Publish Date2025-05-14

On-Brand Devices [Stealth All-Suture Anchor]

00811714035789Stealth All-Suture Anchor, with three 1.5mm Suture Tapes
00811714035772Stealth All-Suture Anchor, with two 1.5mm Suture Tapes
00811714036373Stealth All-Suture Anchor, with two 1.5mm Suture Tapes

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