FDA.reportPublic FDA data

Proform Hip System

Primary DI
10840843100119
Brand
Proform Hip System
Company
GLOBUS MEDICAL, INC.
Model
SC1156-6.5-35
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
OTC
false
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
10840843100119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084310011910840843100119

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
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
008100743075366.0 x 55mm Bone Screw Fastener STOsteocentric Technologies, Inc.JDO2025-09-26
008100743075436.0 x 60mm Bone Screw Fastener STOsteocentric Technologies, Inc.JDO2025-09-26
008100743075506.0 x 65mm Bone Screw Fastener STOsteocentric Technologies, Inc.JDO2025-09-26
0081007430898411 X 75mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081007430997411 X 80mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081007430998111 X 85mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081007430999811 X 90mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911000711 X 95mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911001411 X 100mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911002111 X 105mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911003811 X 110mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911004513 X 75mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911005213 X 80mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911006913 X 85mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911007613 X 90mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911008313 X 95mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911009013 X 100mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911010613 X 105mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911011313 X 110mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911012013 X 115mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911013713 X 120mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911014415 X 75mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911015115 X 80mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911016815 X 85mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911017515 X 90mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911018215 X 95mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911019915 X 100mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911020515 X 105mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911021215 X 110mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
008401944726473P Hip SystemORTHOPEDIATRICS CORP.JDO2025-06-19