FDA.reportPublic FDA data

ProClass Hip System

Primary DI
10840843107019
Brand
ProClass Hip System
Company
GLOBUS MEDICAL, INC.
Model
SC2656-6
Published
2015-02-10
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

Product Codes#

Code, Name table
CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840843107019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084310701910840843107019

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139105691
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01
00889095782486CREO6200.14052019-08-01
00193982647650ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.31272026-02-10
00193982647667ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.37202026-02-10
00193982647674ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50212026-02-10
00193982647681ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50222026-02-10
00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
00193982534028ANTHEM1181.82032026-01-27
00193982534035ANTHEM1181.82042026-01-27
00193982534042ANTHEM1181.82052026-01-27
00193982534059ANTHEM1181.82062026-01-27
00193982534066ANTHEM1181.82072026-01-27
00193982534073ANTHEM1181.82082026-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844693367implaFit®implantcast GmbHLZO2026-03-26
04048844693411implaFit®implantcast GmbHLZO2026-03-26
04048844693442implaFit®implantcast GmbHLZO2026-03-26
04048844693510implaFit®implantcast GmbHLZO2026-03-26
04048844693565implaFit®implantcast GmbHLZO2026-03-26
04048844693596implaFit®implantcast GmbHLZO2026-03-26
04048844731977implaFit®implantcast GmbHLZO2026-03-20
04048844732042implaFit®implantcast GmbHLZO2026-03-20
04048844732059implaFit®implantcast GmbHLZO2026-03-20
04048844732080implaFit®implantcast GmbHLZO2026-03-20
04048844732097implaFit®implantcast GmbHLZO2026-03-20
10885862660145N/AExactech, Inc.LZO2026-03-19
10885862660152N/AExactech, Inc.LZO2026-03-19
10885862660169N/AExactech, Inc.LZO2026-03-19
10885862660176N/AExactech, Inc.LZO2026-03-19
10885862660183N/AExactech, Inc.LZO2026-03-19
10885862660190N/AExactech, Inc.LZO2026-03-19
10885862660206N/AExactech, Inc.LZO2026-03-19
10885862660213N/AExactech, Inc.LZO2026-03-19
10885862660220N/AExactech, Inc.LZO2026-03-19
10885862660237N/AExactech, Inc.LZO2026-03-19
10885862660244N/AExactech, Inc.LZO2026-03-19
10885862660251N/AExactech, Inc.LZO2026-03-19
10885862660268N/AExactech, Inc.LZO2026-03-19
10885862660275N/AExactech, Inc.LZO2026-03-19
10885862660282N/AExactech, Inc.LZO2026-03-19
10885862660299N/AExactech, Inc.LZO2026-03-19
10885862660305N/AExactech, Inc.LZO2026-03-19
10885862660312N/AExactech, Inc.LZO2026-03-19
10885862660329N/AExactech, Inc.LZO2026-03-19