FDA.reportPublic FDA data

Consensus Knee System

Primary DI
00840286854269
Brand
Consensus Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2800-1-3200
Catalog number
2800-1-3200
Device description
Patella Caliper
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286854269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286854269008402868542698402868542690840286854269

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. 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
00840286860147Tahoe Unicompartmental Knee System3000-0-17013000-0-17012026-07-10
00840286860154Tahoe Unicompartmental Knee System3000-0-17023000-0-17022026-07-10
00840286860161Tahoe Unicompartmental Knee System3000-0-17033000-0-17032026-07-10
00840286860178Tahoe Unicompartmental Knee System3000-0-17043000-0-17042026-07-10
00840286860185Tahoe Unicompartmental Knee System3000-0-17053000-0-17052026-07-10
00840286860192Tahoe Unicompartmental Knee System3000-0-17063000-0-17062026-07-10
00840286860208Tahoe Unicompartmental Knee System3000-0-17073000-0-17072026-07-10
00840286860215Tahoe Unicompartmental Knee System3000-0-17083000-0-17082026-07-10
00840286860239Tahoe Unicompartmental Knee System3000-0-16023000-0-16022026-07-10
00840286860246Tahoe Unicompartmental Knee System3000-0-16033000-0-16032026-07-10
00840286860253Tahoe Unicompartmental Knee System3000-0-16043000-0-16042026-07-10
00840286860260Tahoe Unicompartmental Knee System3000-0-16053000-0-16052026-07-10
00840286860277Tahoe Unicompartmental Knee System3000-0-16063000-0-16062026-07-10
00840286860284Tahoe Unicompartmental Knee System3000-0-16073000-0-16072026-07-10
00840286860291Tahoe Unicompartmental Knee System3000-0-16083000-0-16082026-07-10
00840286860307Tahoe Unicompartmental Knee System3600-0-00003600-0-00002026-07-10
00840286860314Tahoe Unicompartmental Knee System3600-0-00013600-0-00012026-07-10
00840286860321Tahoe Unicompartmental Knee System3600-0-00023600-0-00022026-07-10
00840286860338Tahoe Unicompartmental Knee System3600-0-00033600-0-00032026-07-10
00840286860345Tahoe Unicompartmental Knee System3600-0-00043600-0-00042026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
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00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03