Large Fragment Active Plating System

Primary DI
00866204000266
Brand
Large Fragment Active Plating System
Company
Incipio Devices
Model
00-505-000-34
Device description
5mm Locking Screw, 34mm
Published
2016-02-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142938000G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.2014-11-26HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866204000266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866204000266008662040002668662040002660866204000266

GMDN Terms#

Term, Definition table
TermDefinition
Hip internal fixation systemAn assembly of implantable devices designed to treat fractures of the hip. It typically includes a metal plate that is held in position with fasteners such as screws and nails, or bolts, nuts and washers. The assembly is typically intended to treat stable or unstable intertrochanteric, pertrochanteric, and/or base of neck hip fractures.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042094056
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
00866204000204Large Fragment Active Plating System00-505-050-072016-02-15
00866204000211Large Fragment Active Plating System00-505-050-092016-02-15
00866204000228Large Fragment Active Plating System00-505-000-242016-02-24
00866204000235Large Fragment Active Plating System00-505-000-262016-02-24
00866204000242Large Fragment Active Plating System00-505-000-282016-02-24
00866204000259Large Fragment Active Plating System00-505-000-302016-02-24

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Primary DI, Brand, Company table
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