FDA.reportPublic FDA data

Consensus Knee System/Revision Knee System

Primary DI
00840286855044
Brand
Consensus Knee System/Revision Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2800-0-0232
Catalog number
2800-0-0232
Device description
"Fixation Pin, Ø 3.2mm, 2"" Long"
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFCDriver, Surgical, Pin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFCDriver, Surgical, PinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286855044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286855044008402868550448402868550440840286855044

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
00840286841597Consensus Hip System/UniSyn Hip System4410-10020-A4410-10020-A2025-05-22
00840286841962Consensus Hip System1800-0-08401800-0-08402025-05-22
00840286843034Consensus Knee System/Revision Knee System2800-0-07052800-0-07052025-05-22
00840286847162Tahoe Unicompartmental Knee System3000-0-00793000-0-00792025-05-22
00840286847650Tahoe Unicompartmental Knee System3000-0-00733000-0-00732025-05-22
00840286847728Tahoe Unicompartmental Knee System3000-0-00613000-0-00612025-05-22
00840286853897Consensus Hip System1800-0-08451800-0-08452025-05-22
00840286855105Consensus Knee System/Revision Knee System2800-0-07062800-0-07062025-05-22
00840286855112Consensus Knee System/Revision Knee System2800-0-07072800-0-07072025-05-22
00840286855129Consensus Knee System/Revision Knee System2800-0-07082800-0-07082025-05-22
00840286855174CS2 Acetabular System1800-0-15221800-0-15222025-05-22
00840286840958TaperSet Hip System1910-0-00101910-0-00102025-05-21
00840286840996TaperSet Hip System1910-1-00121910-1-00122025-05-21
00840286845182Consensus Knee System2800-0-29502800-0-29502025-05-21
00840286845588Consensus Knee System2800-1-08002800-1-08002025-05-21
00840286840989Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System4410-20070-A4410-20070-A2025-05-14
00840286843959UniSyn Hip System4410-20031-A4410-20031-A2025-05-14
00840286855082Consensus Knee System/Revision Knee System2800-0-07012800-0-07012025-05-14
00840286855099Consensus Knee System/Revision Knee System2800-0-07022800-0-07022025-05-14
00840286855228CS2 Acetabular System1800-0-15281800-0-15282025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663108645Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCGFC2025-11-12
00842188130304K-WiresTrimed, INC.GFC2025-07-08
00841132197066PediNailORTHOPEDIATRICS CORP.GFC2025-06-05
00840194472401PNP FemurORTHOPEDIATRICS CORP.GFC2025-05-28
00840286842129Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286842136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286846714Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855051Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855068Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855143Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855150Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855167Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286859950Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286843867UniSyn Hip SystemShalby Advanced Technologies, Inc.GFC2025-05-20
14053613292136PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292143PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292150PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613293164PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
04053613293167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
00840286846707Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-14
04042409452987NAaap Implantate AGGFC2025-02-26
04042409453007NAaap Implantate AGGFC2025-02-26
04042409453021NAaap Implantate AGGFC2025-02-26
04042409453045NAaap Implantate AGGFC2025-02-26
00860007230059Insurgical, Inc.Insurgical, Inc.GFC2025-01-17
00860007230066Insurgical, Inc.Insurgical, Inc.GFC2025-01-17
10886982347459NASynthes GmbHGFC2024-08-14
00840194478410Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.GFC2024-08-07