FDA.report

CS2 Acetabular Cup System

Primary DI
00844588015243
Brand
CS2 Acetabular Cup System
Company
CONSENSUS ORTHOPEDICS, INC.
Model
1088-0-3654
Catalog number
1088-0-3654
Device description
Acetabular Insert, +5mm, 10° Hood
Published
2015-10-24
Public version status
Update
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
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications

CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844588015243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588015243008445880152438445880152430844588015243

GMDN Terms

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.

Device Sizes

TypeValueUnit
Outer Diameter36Millimeter

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
824905723
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

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00844588006128Consensus® Knee System2151-0-00022151-0-00022015-10-05
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00844588006142Consensus® Knee System2151-0-00042151-0-00042015-10-05
00844588006159Consensus® Knee System2151-0-00052151-0-00052015-10-05
00844588006166Consensus® Knee System2151-0-00062151-0-00062015-10-05
00844588006173Consensus® Knee System2152-0-00012152-0-00012015-10-05
00844588006180Consensus® Knee System2152-0-00022152-0-00022015-10-05
00844588006197Consensus® Knee System2152-0-00032152-0-00032015-10-05
00844588006203Consensus® Knee System2152-0-00042152-0-00042015-10-05
00844588006210Consensus® Knee System2152-0-00052152-0-00052015-10-05
00844588006227Consensus® Knee System2152-0-00062152-0-00062015-10-05
00844588006234Consensus® Knee System2153-0-00012153-0-00012015-10-05
00844588006241Consensus® Knee System2153-0-00022153-0-00022015-10-05
00844588006258Consensus® Knee System2153-0-00032153-0-00032015-10-05
00844588006265Consensus® Knee System2153-0-00042153-0-00042015-10-05
00844588006272Consensus® Knee System2153-0-00052153-0-00052015-10-05
00844588006289Consensus® Knee System2153-0-00062153-0-00062015-10-05
00844588006296Consensus® Knee System2154-0-00012154-0-00012015-10-05

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08031497003955Interspace GV Hip Spacer 46TECRES SPAKWL2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAKWL2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAKWL2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAKWL2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAKWL2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAKWL2026-02-11
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