FDA.reportPublic FDA data

CS2 Acet. Cup Sys. - VitalitE

Primary DI
00840286807210
Brand
CS2 Acet. Cup Sys. - VitalitE
Company
Shalby Advanced Technologies, Inc.
Model
1177-0-3662
Catalog number
1177-0-3662
Device description
Acet. Insert, Lat. +5mm, VitalitE, 36mm ID, 62mm
Published
2022-01-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286807210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286807210008402868072108402868072100840286807210

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 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
00889024686595G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00889024686601G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00889024686618G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00190446893349DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893363DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893370DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893387DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893400DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893424DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893431DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893448DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893486DJO SURGICALEncore Medical, L.P.OQG2025-12-04
08033390270267ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270274ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270281ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270298ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270304ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270311ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270328ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270335ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277211ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277228ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277235ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277242ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277259ArTTLIMACORPORATE SPAOQG2025-09-25
08033390286794ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300315ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300322ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300339ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300346ArTTLIMACORPORATE SPAOQG2025-09-25