FDA.reportPublic FDA data

GRAFTMAX

Primary DI
10845854042229
Brand
GRAFTMAX
Company
Conmed Corporation
Model
KS-ALB
Catalog number
KS-ALB
Device description
GraftMax Button ALB (Adjustable Loop Button)
Published
2015-10-24
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
GATSuture, nonabsorbable, synthetic, polyethylene
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070780000CONMED LINVATEC XO BUTTONConmed Linvatec2007-08-21MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854042226PackageGS11In Commercial Distribution
10845854042229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585404222620845854042226
1084585404222910845854042229

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)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24
20845854036584SEQUENTMR004CMR004C2015-10-24
10653405044703CORE DYNAMICSCD1406CD14062026-03-23
10653405045083CORE DYNAMICSCD1608FHCD1608FH2026-03-24
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655501Argo KnotlessConmed CorporationGAT2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
20845854655518Argo KnotlessConmed CorporationGAT2026-09-25
14026704420305DEKNATELTELEFLEX INCORPORATEDGAT2026-09-21
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-06-24
10193489104523MEDLINEMEDLINE INDUSTRIES, INC.MBI2024-10-08
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2024-09-19
10193489104516MEDLINEMEDLINE INDUSTRIES, INC.MBI2024-07-11
14026704738028DEKNATELTELEFLEX INCORPORATEDGAT2021-08-03
34026704592242DEKNATELTELEFLEX INCORPORATEDGAT2021-01-22
00815432028986SPEEDBUTTONCROSSROADS EXTREMITY SYSTEMSMBI2021-01-22
14026704427021DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
34026704422228DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
34026704426073DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
14026704647825DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704647856DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670410DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670472DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670533DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670540DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670601DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716286DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716293DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716316DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716330DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716347DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716354DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716408DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716422DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27