FDA.reportPublic FDA data

Proform Hip System

Primary DI
10840843100126
Brand
Proform Hip System
Company
GLOBUS MEDICAL, INC.
Model
SC1156-6.5-40
Device description
Bone Screw
Published
2015-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDODevice, Fixation, Proximal Femoral, Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840843100126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084310012610840843100126

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139105691
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849044040517N/A632.3002016-01-23
00193982662295ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00012026-03-30
00193982662301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00022026-03-30
00193982662318ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00032026-03-30
00193982662325ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00502026-03-30
00193982662332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00702026-03-30
00193982662349ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00902026-03-30
00193982662356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10502026-03-30
00193982662363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10702026-03-30
00193982662370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10902026-03-30
00193982662387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20502026-03-30
00193982662394ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20902026-03-30
00193982677411ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20702026-03-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982174994DHSSynthes GmbHJDO2015-09-14
10886982175007DHSSynthes GmbHJDO2015-09-14
10886982175014DHSSynthes GmbHJDO2015-09-14
10886982175021DHSSynthes GmbHJDO2015-09-14
10886982175038DHSSynthes GmbHJDO2015-09-14
10886982175045DHSSynthes GmbHJDO2015-09-14
10886982175052DHSSynthes GmbHJDO2015-09-14
10886982175069DHSSynthes GmbHJDO2015-09-14
10886982175076DHSSynthes GmbHJDO2015-09-14
10886982175083DHSSynthes GmbHJDO2015-09-14
10886982175090DHSSynthes GmbHJDO2015-09-14
10886982175106DHSSynthes GmbHJDO2015-09-14
10886982175113DHSSynthes GmbHJDO2015-09-14
10886982175120DHSSynthes GmbHJDO2015-09-14
10886982175137DHSSynthes GmbHJDO2015-09-14
10886982175144DHSSynthes GmbHJDO2015-09-14
10886982175151DHSSynthes GmbHJDO2015-09-14
10886982175168DHSSynthes GmbHJDO2015-09-14
10886982175175DHSSynthes GmbHJDO2015-09-14
10886982175182DHSSynthes GmbHJDO2015-09-14
10886982175212DHSSynthes GmbHJDO2015-09-14
10886982175229DHSSynthes GmbHJDO2015-09-14
10886982175236DHSSynthes GmbHJDO2015-09-14
10886982175243DHSSynthes GmbHJDO2015-09-14
10886982175250DHSSynthes GmbHJDO2015-09-14
10886982175267DHSSynthes GmbHJDO2015-09-14
10886982175274DHSSynthes GmbHJDO2015-09-14
10886982175281DHSSynthes GmbHJDO2015-09-14
10886982175298DHSSynthes GmbHJDO2015-09-14
10886982175304DHSSynthes GmbHJDO2015-09-14