FDA.reportPublic FDA data

Shadow Mini All-Suture Anchor

Primary DI
00811714036397
Brand
Shadow Mini All-Suture Anchor
Company
RESPONSIVE ORTHOPEDICS LLC
Model
285951
Catalog number
285951
Device description
Shadow Mini All-Suture Anchor, with one #2 Suture
Published
2025-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230094000Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC2023-08-25MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811714036397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811714036397008117140363978117140363970811714036397

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002745858
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811714036403Shadow Mini Instruments2859522859522026-02-03
00811714036427Shadow Knotless Instruments2859542859542026-02-03
00811714036380Shadow Instruments2859502859502025-12-31
00811714036373Shadow All-Suture Anchor2859492859492025-05-14
00811714036625Mini Superhawk Suture Anchor2859802859802025-12-09
00811714036632Mini Superhawk2859752859752025-12-09
00811714036663Mini Superhawk2859782859782025-12-09
00811714036670Mini Superhawk2859792859792025-12-09
00811714036731Osprey Suture Anchor2859852025-12-09
00811714036748Mini Superhawk Suture Anchor2859812859812025-12-09
00811714036144Superhawk2859252859252025-05-14
00811714036151Superhawk2859262859262025-05-14
00811714036168Superhawk2859272859272025-05-14
00811714036199Superhawk2859302859302025-05-14
00811714036205Superhawk2859312859312025-05-14
00811714036212Superhawk2859322859322025-05-14
00811714036229Superhawk2859332859332025-05-14
00811714036236Superhawk2859342859342025-05-14
00811714036243Superhawk2859362859362025-05-14
00811714036250Superhawk2859372859372025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993303863AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: WhiteAuxein Medical Private LimitedMBI2026-04-30
08903993457009AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457368AUXILOCK® 2.8mm Titanium Screw-In Suture Anchor With One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457375AUXILOCK® 3.5mm Titanium Screw-In Suture Anchor With Two #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457467AUXILOCK® GFS Mini, Loop: 15mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-30
08903993457450AUXILOCK® GFS Mini, Loop: 12mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-18
08903993499887AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid:White/BlAuxein Medical Private LimitedMBI2026-04-18
08720629959573SINEFIXBaat Medical Products B.V.MBI2026-04-01
08721515510151SINEFIXBaat Medical Products B.V.MBI2026-04-01
08101755018820HerculesIn2Bones USA, LLCMBI2026-03-30
08437019739744QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
08437019739751QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
08437019739768QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14
07613327661989KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327661996KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662009KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662023KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
08437019739867WasherCap™ Fixation System 11mmABANZA TECNOMED SL.MBI2025-03-10
08437019739898WasherCap Mini Fixation system 3.5mmABANZA TECNOMED SL.MBI2025-02-25
08437019739904WasherCap Mini Fixation system 4.5mmABANZA TECNOMED SL.MBI2025-02-25
08800298539143GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539150GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539167GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539174GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539228GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539235GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
09348215029104Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26
09348215029111Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26
09348215029128Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26