FDA.reportPublic FDA data

Olecranon Plate, 2 Hole, Right

Primary DI
10812269022825
Brand
Olecranon Plate, 2 Hole, Right
Company
MIAMI DEVICE SOLUTIONS LLC
Model
MDS160102R
Catalog number
MDS160102R
Device description
Olecranon Plate, 2 Hole, Right
Published
2017-10-09
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812269022825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081226902282510812269022825

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; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(786) 422-1400customerservice@miamidevicesolutions.com

Regulatory Flags#

DUNS number
078703080
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812269021804Distal Radius PlateMDS14010601MDS140106012016-09-20
10812269021811Distal Radius PlateMDS14010602MDS140106022016-09-20
10812269022603Distal Radius PlateMDS14010503MDS140105032016-09-20
10812269022610Distal Radius PlateMDS14010603MDS140106032016-09-20
10812269022665Olecranon Plate, 4 Hole, Left MDS160104LMDS160104L2017-10-09
10812269022818Olecranon Plate, 2 Hole, LeftMDS160102LMDS160102L2017-10-10
10812269022832Olecranon Plate, 4 Hole, RightMDS160104RMDS160104R2017-10-09
10812269023662Extra Articular Distal Humerus Plate MDS170104LMDS170104L2018-01-02
10812269023679Extra Articular Distal Humerus PlateMDS170106LMDS170106L2018-01-02
10812269023686Extra Articular Distal Humerus Plate MDS170108LMDS170108L2018-01-02
10812269023693Extra Articular Distal Humerus Plate MDS170110LMDS170110L2018-01-02
10812269023709Extra Articular Distal Humerus PlateMDS170112LMDS170112L2018-01-02
10812269023716Extra Articular Distal Humerus PlateMDS170114LMDS170114L2018-01-02
10812269023723Extra Articular Distal Humerus PlateMDS170104RMDS170104R2018-01-02
10812269023730Extra Articular Distal Humerus PlateMDS170106RMDS170106R2018-01-02
10812269023747Extra Articular Distal Humerus PlateMDS170108RMDS170108R2018-01-02
10812269023754Extra Articular Distal Humerus PlateMDS170110RMDS170110R2018-01-02
10812269023761Extra Articular Distal Humerus PlateMDS170112RMDS170112R2018-01-02
10812269023778Extra Articular Distal Humerus PlateMDS170114RMDS170114R2018-01-02
10812269025819Distal Radius PlateMDS1401N03LMDS1401N03L2018-12-17

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
10850070500125CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500132CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500149CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500156CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500163CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500170CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500187CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500194CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500200CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500217CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500224CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500231CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500248CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500255CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500262CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500279CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500286CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500293CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500309CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500316CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500323CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500330CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500347CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500354CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22