FDA.reportPublic FDA data

GPC

Primary DI
08905892010064
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
PFA11.17T
Device description
intraHEAL Proximal Femoral Nail, Advanced Dia. 11 mm, 170 mm Length- Titanium
Published
2025-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203811000GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited2022-02-10HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08905892010064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08905892010064089058920100648905892010064

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis intramedullary nail, non-distractingA rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9205302602info@gpcmedical.com

Regulatory Flags#

DUNS number
915882579
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08905892010033GPCPFA10.17T2025-09-19
08905892042751GPCECPFAT2025-09-19
08905892042959GPCECMTT2025-09-19
08905892105418GPC848.06T2025-09-10
08905892105425GPC848.07T2025-09-10
08905892105432GPC848.08T2025-09-10
08905892105449GPC848.09T2025-09-10
08905892105456GPC848.10T2025-09-10
08905892105463GPC848.11T2025-09-10
08905892105470GPC848.11T2025-09-10
08905892105487GPC848.14T2025-09-10
08905892105494GPC848.16T2025-09-10
08905892105500GPC848.18T2025-09-10
08905892105616GPC849.06T2025-09-10
08905892105623GPC849.07T2025-09-10
08905892105630GPC849.08T2025-09-10
08905892105647GPC849.09T2025-09-10
08905892105654GPC849.10T2025-09-10
08905892105661GPC849.11T2025-09-10
08905892105678GPC849.12T2025-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
10855068008003CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008010CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008027CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008034CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008041CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008058CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008065CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008072CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008089CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008096CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008102CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
07898624869140NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869157NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869164NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869171NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869188NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869195NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869201NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869218NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869225NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869232NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869249NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869256NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06