Distal Elbow Plating System

Primary DI
00841506141459
Brand
Distal Elbow Plating System
Company
SKELETAL DYNAMICS L.L.C.
Model
FreeFix, Proximal Ulna Plate, 7 Slot, Left
Catalog number
PUPF-7SL
Device description
FreeFix, Proximal Ulna Plate, 7 Slot, Left
Published
2026-03-05
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231623000Distal Elbow Plating SystemSkeletal Dynamics, Inc.2023-08-28HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506141459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506141459008415061414598415061414590841506141459

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, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
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
00885556836187Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836163Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836170Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836194Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836200Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836217Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836224Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836248Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836255Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836262Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835999Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836002Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836019Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836026Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836033Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836040Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836057Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836064Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836071Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836088Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836095Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836118Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836125Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836132Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836149Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836156Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556838785Total Foot System 2Smith & Nephew, Inc.HRS2022-12-21
00885556838785Total Foot System 2Smith & Nephew, Inc.HWC2022-12-21
00888867007475Arthrex®ARTHREX, INC.HRS2017-02-15
00888867007499Arthrex®ARTHREX, INC.HRS2017-02-15