FDA.reportPublic FDA data

GENESYS PressFT, Hi-Fi

Primary DI
30845854027893
Brand
GENESYS PressFT, Hi-Fi
Company
Conmed Corporation
Model
NB261H
Catalog number
NB261H
Device description
GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
Published
2024-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
K121890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121890000GENESYS PRESSFT SUTURE ANCHORLinvatec Corporation D/B/A Conmed Linvatec2012-08-22MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854027893PackageGS11In Commercial Distribution
10845854027899PreviousGS10
20845854027896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585402789330845854027893
1084585402789910845854027899
2084585402789620845854027896

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Temperature040 Degrees Celsius
Storage Environment Temperature0104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10886705033317GRYPHON XMedos International SàrlMAI2025-04-22
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
20653405988707Argo Knotless GENESYSConmed CorporationMAI2024-07-22
20653405988714Argo Knotless GENESYSConmed CorporationMAI2024-07-22
10845854045794CROSSFT, HI-FIConmed CorporationMAI2024-04-18
20653405988646Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988653ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988660ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988677Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988684ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988691ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
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