FDA.reportPublic FDA data

GPC

Primary DI
08905892111129
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
906.06TR
Device description
fixLOCK Proximal Tibia Plate 3.5 mm - Titanium - Left/Right
Published
2025-09-10
Public version status
Update
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153716000GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.2016-05-17HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08905892111129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08905892111129089058921111298905892111129

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01