FDA.reportPublic FDA data

GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR

Primary DI
00850005827276
Brand
GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR
Company
Genesis Biologics, Inc.
Model
10KPN4751
Catalog number
10KPN4751
Device description
4.75MM HYBRID KNOTLESS DUAL THREAD ANCHOR
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
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203523000Fixone hybrid knotless anchorAju Pharm Co., Ltd.2021-12-25MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005827276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005827276008500058272768500058272760850005827276

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA 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 can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

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
00850005827283GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR10KPN550110KPN55012023-03-16
00850005827290GENESIS ALL SUTURE ANCHOR10JS250310JS25032023-03-16
00850005827306GENESIS AWL40AWL04540AWL0452023-03-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHMAI2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHMAI2025-10-01
07613327662016KNOTILUS+STRYKER CORPORATIONMAI2025-06-16
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
10886705001040LUPINEDEPUY MITEK, LLCMAI2025-03-04
10886705023868HEALIX TRANSTENDMedos International SàrlMAI2025-03-04
07613327547429DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547436DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547443DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547450DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547467DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
10845854045794CROSSFT, HI-FIConmed CorporationMAI2024-04-18
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHMAI2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12