FDA.report

Consensus Hip System

Primary DI
00840286802598
Brand
Consensus Hip System
Company
Shalby Advanced Technologies, Inc.
Model
1014-0-0040
Catalog number
1014-0-0040
Device description
Bipolar Head, 40mm OD
Published
2022-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840286802598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286802598008402868025988402868025980840286802598

GMDN Terms

TermDefinition
Bipolar femoral head outer component, hemiarthroplastyAn implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags

DUNS number
085976260
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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

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