FDA.reportPublic FDA data

GENESIS ALL SUTURE ANCHOR

Primary DI
00850005827290
Brand
GENESIS ALL SUTURE ANCHOR
Company
Genesis Biologics, Inc.
Model
10JS2503
Catalog number
10JS2503
Device description
2.5MM ALL SUTURE ANCHOR, SH
Published
2023-03-16
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

Contact Domains#

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
K192709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192709000Fixone All Suture AnchorAju Pharm Co., Ltd.2020-12-15MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005827290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005827290008500058272908500058272900850005827290

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

Contacts#

Phone, Email table
PhoneEmail
(657) 888-6243ORDERS@GENESISBIOLOGICS.COM

Regulatory Flags#

DUNS number
016463487
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005827368AlternatiV+ Screw-In Anchor20BN475320BN47532024-10-08
00850005827375AlternatiV+ Screw-In Anchor20BN550320BN55032024-10-08
00850005827382AlternatiV+ Max Knotless Anchor20KPN475120KPN47512024-10-08
00850005827399DUAL PITCH AWL/TAPPER 4.75MM50AT047550AT04752024-10-08
00850005827405DUAL PITCH AWL/TAPPER 5.5MM50AT055050AT05502024-10-08
00850005827412AWL/TAPPER 4.5MM50AWLT4550AWLT452024-10-08
00850005827429AWL 4.5MM50AWL04550AWL0452024-10-08
00850005827436AWL 5.5MM50AWL05550AWL0552024-10-08
00850005827443AWL/TAPPER 5.5MM50AWLT5550AWLT552024-10-08
00850005827450DRILL GUIDE 3.1MM50DG003150DG00312024-10-08
00850005827467DRILL BIT 2.0MM50DB002050DB00202024-10-08
00850005827214GENESIS SCREW-IN SUTURE ANCHOR10B4500310B450032023-03-16
00850005827221GENESIS SCREW-IN SUTURE ANCHOR10B5500310B550032023-03-16
00850005827238GENESIS SCREW-IN SUTURE ANCHOR10B6500310B650032023-03-16
00850005827245GENESIS THREAD SCREW-IN SUTURE ANCHOR10N4750210N475022023-03-16
00850005827252GENESIS THREAD SCREW-IN SUTURE ANCHOR10N45500210N4550022023-03-16
00850005827269GENESIS PUSH-IN SUTURE ANCHOR10S3000210S300022023-03-16
00850005827276GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR10KPN475110KPN47512023-03-16
00850005827283GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR10KPN550110KPN55012023-03-16
00850005827306GENESIS AWL40AWL04540AWL0452023-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918613ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
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
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
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2024-09-19
08720629950464SINEFIXBaat Medical Products B.V.MBI2023-04-11