FDA.reportPublic FDA data

Consensus Hip System

Primary DI
00840286845526
Brand
Consensus Hip System
Company
Shalby Advanced Technologies, Inc.
Model
2800-0-2234
Catalog number
2800-0-2234
Device description
Tibial Stem Punch, Sz 3/4
Published
2025-05-21
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
LRYPunch, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286845526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286845526008402868455268402868455260840286845526

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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
00840286841597Consensus Hip System/UniSyn Hip System4410-10020-A4410-10020-A2025-05-22
00840286841962Consensus Hip System1800-0-08401800-0-08402025-05-22
00840286843034Consensus Knee System/Revision Knee System2800-0-07052800-0-07052025-05-22
00840286847162Tahoe Unicompartmental Knee System3000-0-00793000-0-00792025-05-22
00840286847650Tahoe Unicompartmental Knee System3000-0-00733000-0-00732025-05-22
00840286847728Tahoe Unicompartmental Knee System3000-0-00613000-0-00612025-05-22
00840286853897Consensus Hip System1800-0-08451800-0-08452025-05-22
00840286855105Consensus Knee System/Revision Knee System2800-0-07062800-0-07062025-05-22
00840286855112Consensus Knee System/Revision Knee System2800-0-07072800-0-07072025-05-22
00840286855129Consensus Knee System/Revision Knee System2800-0-07082800-0-07082025-05-22
00840286855174CS2 Acetabular System1800-0-15221800-0-15222025-05-22
00840286840958TaperSet Hip System1910-0-00101910-0-00102025-05-21
00840286840996TaperSet Hip System1910-1-00121910-1-00122025-05-21
00840286845182Consensus Knee System2800-0-29502800-0-29502025-05-21
00840286845588Consensus Knee System2800-1-08002800-1-08002025-05-21
00840286840989Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System4410-20070-A4410-20070-A2025-05-14
00840286843959UniSyn Hip System4410-20031-A4410-20031-A2025-05-14
00840286855082Consensus Knee System/Revision Knee System2800-0-07012800-0-07012025-05-14
00840286855099Consensus Knee System/Revision Knee System2800-0-07022800-0-07022025-05-14
00840286855228CS2 Acetabular System1800-0-15281800-0-15282025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10304040193270Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193287Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193294Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193300Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193317Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193324Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193331Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193348Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193355Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040177829Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177836Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177850Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177867Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177874Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177881Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177904Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177843Henry ScheinHENRY SCHEIN, INC.LRY2025-02-17
10304040177898Henry ScheinHENRY SCHEIN, INC.LRY2025-02-17
B8034800300ORTHOMEDORTHO-MED, INC.LRY2024-02-13
B8034800320ORTHOMEDORTHO-MED, INC.LRY2024-02-13
B8034800330ORTHOMEDORTHO-MED, INC.LRY2024-02-13
B8034708660ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708680ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708700ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708720ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708730ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708740ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708750ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708780ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708790ORTHOMEDORTHO-MED, INC.LRY2023-09-12