FDA.reportPublic FDA data

Summit Patella Plating System

Primary DI
00860004838012
Brand
Summit Patella Plating System
Company
Endeavor Orthopaedics, LLC
Model
Small
Catalog number
1316-3001
Device description
Sterile, Single use, Patella Fracture Repair Kit, Small
Published
2022-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203408000Summit Patella Plating SystemEndeavor Orthopaedics, LLC2021-07-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004838012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004838012008600048380128600048380120860004838012

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-405-8862info@endeavorortho.com

Regulatory Flags#

DUNS number
107767417
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004838005Summit Patella Plating SystemStandard1316-30002022-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
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00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
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00815432024360DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024377DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024391DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024407DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024421DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024438DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024346DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024414DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024445DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024452DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024469DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
00815432024384DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-10
00815432025473MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025480MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025497MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025503MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025510MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025541MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432025572MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2020-03-20
00815432026524MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026531MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026548MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026555MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04
00815432026562MotoBANDCROSSROADS EXTREMITY SYSTEMSHRS2019-03-04