FDA.reportPublic FDA data

CONCEPT GRAFIX

Primary DI
10845854036266
Brand
CONCEPT GRAFIX
Company
Conmed Corporation
Model
PS8820
Catalog number
PS8820
Device description
CONCEPT GRAFIX GRAFT PREPARATION TABLE
Published
2022-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854036263Direct MarkingGS10
10845854036266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585403626320845854036263
1084585403626610845854036266

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament graft preparation stationAn assembly of devices designed to provide the operator with a workstation for the preparation and pretensioning of a ligament and/or tendon graft prior to implantation. It typically consists of a work base to provide a stable platform on which the graft can be treated, various types of adjustable and fixed posts including soft tissue clamps and tensioning devices, a graft sizing block, and tools to hold and tension a graft (e.g., an Allen key). It may be used for a variety of bone-tendon-bone and soft tissue grafts such as semitendinosus patellar tendon, quadriceps tendon, or patellar tendon grafts for anterior cruciate ligament (ACL) reconstruction. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Manufacturing 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
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
00810112599534PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599541PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599558PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599565PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599572PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599589PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599596PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599602PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599619PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599626PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599633PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599640PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599657PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599664PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599671PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599688PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599695PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599701PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599718PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599343PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-07
00810112599350PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-07