FDA.reportPublic FDA data

Consensus Knee System/Revision Knee System

Primary DI
00840286842167
Brand
Consensus Knee System/Revision Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2800-0-0132
Catalog number
2800-0-0132
Device description
Drill Bit, 3.2mm
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
HTWBit, Drill
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286842167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286842167008402868421678402868421670840286842167

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191814Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29