FDA.reportPublic FDA data

osteo-WEDGE2 30 Degree Angulated Bone Plate Implant, Large

Primary DI
M621GM504300
Brand
osteo-WEDGE2 30 Degree Angulated Bone Plate Implant, Large
Company
Graham Medical Technologies, L.L.C.
Model
GM-504-30
Catalog number
GM-504-30
Device description
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Published
2020-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162179000osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica2017-01-10HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M621GM504300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828660345
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
M621CARRYINGCASE0osteo-WEDGE Opening Wedge Bone Locking System OWCarryingCase-KitCarryingCase2017-02-14
M621CP1505FG0HyProCure Sizer 05CP15-05-FGCP15-05-FG2017-02-14
M621CP1506FG0HyProCure Sizer 06CP15-06-FGCP15-06-FG2017-02-14
M621CP1507FG0HyProCure Sizer 07CP15-07-FGCP15-07-FG2017-02-14
M621CP1508FG0HyProCure Sizer 08CP15-08-FGCP15-08-FG2017-02-14
M621CP1509FG0HyProCure Sizer 09CP15-09-FGCP15-09-FG2017-02-14
M621CP1510FG0HyProCure Sizer 10CP15-10-FGCP15-10-FG2017-02-14
M621GM150010osteo-WEDGE Depth Gauge SleeveGM-150-01GM-150-012017-04-04
M621GM150020osteo-WEDGE Depth Gauge GM-150-02GM-150-022017-04-04
M621GM150030osteo-WEDGE DriverGM-150-03GM-150-032017-04-04
M621GM150040osteo-WEDGE Screw Retainer SleeveGM-150-04GM-150-042017-04-04
M621GM160010osteo-WEDGE Drill GuideGM-160-01GM-160-012017-04-04
M621GM501000osteo-WEDGE Bone Plate 00mmGM-501-00GM-501-002017-04-04
M621GM501020osteo-WEDGE Bone Plate 02mmGM-501-02GM-501-022017-04-04
M621GM501040osteo-WEDGE Bone Plate 04mmGM-501-04GM-501-042017-04-04
M621GM501060osteo-WEDGE Bone Plate 06mmGM-501-06GM-501-062017-04-04
M621GM501080osteo-WEDGE Bone Plate 08mmGM-501-08GM-501-082017-04-04
M621GM501100osteo-WEDGE Bone Plate 10mmGM-501-10GM-501-102017-04-04
M621GMDSLL0Graham Decompression Scissors, Curved Left "11-470-11-CL (14cm/5.5"")"GM-DS-LL2017-01-27
M621GMDSLR0Graham Decompression Scissors, Curved Right"11-470-11-CR (14cm/5.5"")"GM-DS-LR2017-01-27

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