FDA.reportPublic FDA data

Proximal Ulna Plate

Primary DI
00841506131986
Brand
Proximal Ulna Plate
Company
SKELETAL DYNAMICS L.L.C.
Model
Proximal Ulna Plating System
Catalog number
PUP-SYS
Published
2023-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K102103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102103000SKELETAL DYNAMICS STERILIZATION TRAYSSkeletal Dynamics, LLC2010-12-07KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506131986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506131986008415061319868415061319860841506131986

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags#

DUNS number
869056148
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841506134895Threaded Hand NailDGA-THN-20DGA-THN-202026-04-29
00841506140193Threaded Hand NailDRVR-UQC-T8RDRVR-UQC-T8R2026-04-29
00841506140216Threaded Hand NailDRVR-CAN-T10RDRVR-CAN-T10R2026-04-29
00841506140223Threaded Hand NailDRVR-CAN-T8RDRVR-CAN-T8R2026-04-29
00841506141060Threaded Hand NailKWIR-DT-14171KWIR-DT-141712026-04-29
00841506141398Threaded Hand NailHTS-WPHTS-WP2026-04-29
00841506141428Threaded Hand NailKWIR-ST-07152KWIR-ST-071522026-04-29
00841506146546Threaded Hand NailRHS-20012CRHS-20012C2026-04-29
00841506146553Threaded Hand NailRHS-20014CRHS-20014C2026-04-29
00841506146560Threaded Hand NailRHS-20016CRHS-20016C2026-04-29
00841506146577Threaded Hand NailRHS-20018CRHS-20018C2026-04-29
00841506146584Threaded Hand NailRHS-20020CRHS-20020C2026-04-29
00841506146591Threaded Hand NailRHS-20022CRHS-20022C2026-04-29
00841506146607Threaded Hand NailRHS-20024CRHS-20024C2026-04-29
00841506146614Threaded Hand NailRHS-20026CRHS-20026C2026-04-29
00841506146621Threaded Hand NailRHS-20028CRHS-20028C2026-04-29
00841506146638Threaded Hand NailRHS-20032CRHS-20032C2026-04-29
00841506146645Threaded Hand NailRHS-20036CRHS-20036C2026-04-29
00841506146652Threaded Hand NailRHS-20040CRHS-20040C2026-04-29
00841506146669Threaded Hand NailRHS-20044CRHS-20044C2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132452Tools - TWFTrimed, INC.HRS2026-08-18
00842188132230Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132247Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132254Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132261Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132445Tools - TWFTrimed, INC.HRS2026-08-17
00193982096274ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158729ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158774ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158828ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167615ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167660ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167769ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167813ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167868ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167912ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14