FDA.reportPublic FDA data

UniSyn Hip System

Primary DI
00840286843898
Brand
UniSyn Hip System
Company
Shalby Advanced Technologies, Inc.
Model
4410-10030-A
Catalog number
4410-10030-A
Device description
Distal Pilot Remover, UniSyn
Published
2025-05-20
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
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286843898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286843898008402868438988402868438980840286843898

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument extractorA hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10
00841435120365TecometTECOMET INC.HWB2022-10-03
00841435111226TecometTECOMET INC.HWB2020-10-09
00818069014858TecometTECOMET INC.HWB2020-10-09
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00841435100695TecometTECOMET INC.HWB2020-10-09
00818069014339TecometTECOMET INC.HWB2020-08-20
00818069014346TecometTECOMET INC.HWB2020-08-20
00818069014353TecometTECOMET INC.HWB2020-08-20
00818069014360TecometTECOMET INC.HWB2020-08-07
00818069014377TecometTECOMET INC.HWB2020-08-07
00818069014384TecometTECOMET INC.HWB2020-08-07
00818069014391TecometTECOMET INC.HWB2020-08-07
00818069014407TecometTECOMET INC.HWB2020-08-07
00818069014414TecometTECOMET INC.HWB2020-08-07
00863176000324FIBULINKSynthes GmbHHWB2020-03-26
10705034535364NADEPUY SPINE, LLCHWB2019-02-12
10705034535821NADEPUY SPINE, LLCHWB2019-02-12
10705034533650NADEPUY SPINE, LLCHWB2019-01-16
10705034533667NADEPUY SPINE, LLCHWB2019-01-16
10705034533674NADEPUY SPINE, LLCHWB2019-01-16