FDA.reportPublic FDA data

Consensus Knee System

Primary DI
00840286845588
Brand
Consensus Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2800-1-0800
Catalog number
2800-1-0800
Device description
Slap Hammer/Extractor
Published
2025-05-21
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
FZYHammer, Surgical
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286845588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286845588008402868455888402868455880840286845588

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286853163TaperSet Hip System1911-3-10751911-3-10752026-07-09
00840286853170TaperSet Hip System1911-3-11051911-3-11052026-07-09
00840286853187TaperSet Hip System1911-3-11351911-3-11352026-07-09
00840286855587TaperSet Hip System1911-3-11651911-3-11652026-07-09
00840286855921TaperSet Hip System1911-3-12101911-3-12102026-07-09
00840286859929TaperSet Hip System1911-3-10501911-3-10502026-07-09
00840286859943TaperSet Hip System1910-3-10751910-3-10752026-07-09
00840286859967TaperSet Hip System1910-3-11051910-3-11052026-07-09
00840286859974TaperSet Hip System1910-3-11351910-3-11352026-07-09
00840286859981TaperSet Hip System1910-3-11651910-3-11652026-07-09
00840286859998TaperSet Hip System1910-3-12101910-3-12102026-07-09
00840286860000TaperSet Hip System1910-3-10501910-3-10502026-07-09
00840286860086Consensus Knee System55088-0055088-002026-07-09
00840286860093Tahoe Unicompartmental Knee System3000-0-01093000-0-01092026-07-09
00840286860109Tahoe Unicompartmental Knee System3000-0-00753000-0-00752026-07-09
00840286860116Tahoe Unicompartmental Knee System3000-0-00723000-0-00722026-07-09
00840286860123Tahoe Unicompartmental Knee System3000-0-00693000-0-00692026-07-09
00840286860130Tahoe Unicompartmental Knee System3000-0-00703000-0-00702026-07-09
00840286860222Tahoe Unicompartmental Knee System3000-0-16013000-0-16012026-07-09
00840286860390Tahoe Unicompartmental Knee System3000-0-00623000-0-00622026-07-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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ESAM3318021STOMA®Storz am Mark GmbHFZY2020-08-27
ESAM3318171STOMA®Storz am Mark GmbHFZY2020-08-27
00818069014339TecometTECOMET INC.HWB2020-08-20
00818069014346TecometTECOMET INC.HWB2020-08-20
00818069014353TecometTECOMET INC.HWB2020-08-20
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