FDA.reportPublic FDA data

Revision Knee System

Primary DI
00840286842068
Brand
Revision Knee System
Company
Shalby Advanced Technologies, Inc.
Model
2970-0-0027
Catalog number
2970-0-0027
Device description
RKS, Stop Drill Bit, .25 OD x .50 Dp, SS
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286842068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286842068008402868420688402868420680840286842068

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286855648CS2 Acetabular System1905-1-00421905-1-00422025-09-22
00840286856676CS2 Acetabular System1904-2-28581904-2-28582025-09-22
00840286860024Consensus Knee System2800-0-20232800-0-20232025-07-07
00840286860031Consensus Knee System2800-0-20242800-0-20242025-07-07
00840286860079Consensus Knee System2800-0-20252800-0-20252025-07-07
00840286853132Consensus Knee System2800-0-20142800-0-20142025-06-04
00840286841016Bipolar Hip System55050-0055050-002025-05-22
00840286841023Bipolar Hip System1914-2-00001914-2-00002025-05-22
00840286841030Bipolar Hip System1814-0-42441814-0-42442025-05-22
00840286841047Bipolar Hip System1814-0-45471814-0-45472025-05-22
00840286841054Bipolar Hip System1814-0-48501814-0-48502025-05-22
00840286841061Bipolar Hip System1814-0-51531814-0-51532025-05-22
00840286841078Bipolar Hip System1814-0-54561814-0-54562025-05-22
00840286841085Bipolar Hip System1814-0-57591814-0-57592025-05-22
00840286841092Bipolar Hip System1814-0-60621814-0-60622025-05-22
00840286841108Bipolar Hip System1914-0-00421914-0-00422025-05-22
00840286841115Bipolar Hip System1914-0-00431914-0-00432025-05-22
00840286841122Bipolar Hip System1914-0-00441914-0-00442025-05-22
00840286841139Bipolar Hip System1914-0-00451914-0-00452025-05-22
00840286841146Bipolar Hip System1914-0-00461914-0-00462025-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536800244Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
00840536800251Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
07901125600706Minidriver SolarisGM DOS REIS INDUSTRIA E COMERCIO LTDAKIJ2026-02-20
07649988202209FiberLocker PowerUnit - Transfer ShieldZuriMED Technologies AGKIJ2026-02-02
07649988202278FiberLocker PowerUnit - HandpieceZuriMED Technologies AGKIJ2026-02-02
07649988202285FiberLocker PowerUnit - Motor PackZuriMED Technologies AGKIJ2026-02-02
07649988202292FiberLocker PowerUnit - Charging StationZuriMED Technologies AGKIJ2026-02-02
08800038060319EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060326EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060333EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060340EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
00850056900102Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900119Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900126Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900133Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900140Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900157Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900164Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
08800068959348LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959355LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959645LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800017270258BENCOX Surgical InstrumentsCorentec Co., LtdKIJ2025-09-24
08809260475052TD-AUTOSaeshin Precision Co., Ltd.KIJ2025-07-22
008401944934513P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937723P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937893P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944938883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863123P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863293P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321866883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19