FDA.reportPublic FDA data

Consensus Knee System

Primary DI
00840286857192
Brand
Consensus Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2800-0-3000
Catalog number
2800-0-3000
Device description
Patellar Osteotomy Guide
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286857192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286857192008402868571928402868571920840286857192

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M697X07901121Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FZX2026-07-08
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
09421038412244KA Femoral Alignment Guide - Medial PaddleENZTEC LIMITEDFZX2026-06-24
09421038412251KA Femoral Alignment Guide - Lateral PaddleENZTEC LIMITEDFZX2026-06-24
09421038412268KA Femoral Alignment Guide - FanENZTEC LIMITEDFZX2026-06-24
09421038412275KA Femoral Alignment Guide – IM GuideENZTEC LIMITEDFZX2026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide ConnectorENZTEC LIMITEDFZX2026-06-24
03700879518701NANOVASTEPFZX2026-06-23
03700879518718NANOVASTEPFZX2026-06-23
03700879518725NANOVASTEPFZX2026-06-23
03700879518732NANOVASTEPFZX2026-06-23
08800089483440Surgical InstrumentJeil Medical CorporationFZX2026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2026-06-10
008401944960013P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944960183P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962543P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962613P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971903P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944972063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
00889024701526Identity® Shoulder SystemZimmer, Inc.FZX2026-06-10
00889795154538Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154545Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154613Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02