Dinamic T Humerus

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: DINAMIC T HUMERUS FDA UDI
Generic Name: Bone nail end-cap FDA UDI
Device Name: End cap for humeral nail. Lenght: 8mm (standard end cap + 4mm). Material: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI
Model / Reference: End cap 4mm FDA UDI
Description: End cap for humeral nail. Lenght: 8mm (standard end cap + 4mm). Material: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI

Identifiers

Catalog Number: DT731004 FDA UDI
Primary DI / UDI-DI: 08032909626724 FDA UDI
510(k) Number: K113387 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Bone nail end-cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 6.8 Millimeter FDA UDI
Outer Diameter — 9.7 Millimeter FDA UDI

Category: Bone nail end-cap

Dinamic T Humerus by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone nail end-cap.

Phantom® Fibula Nail System — Paragon 28 · Class II
PTN PERITROCHANTERIC NAIL — Biomet Orthopedics, Inc. · Class II
Micro Screws (INOX) — devemed GmbH · Class IIb
AJAX Nail — Auxein Medical Private Limited · Class II
PEDIATRIC LOCKING NAIL SYSTEM — Biomet Orthopedics, Inc. · Class II
PNP Femur — ORTHOPEDIATRICS CORP. · Class II
PNP Femur — ORTHOPEDIATRICS CORP. · Class II
EXPert Nail — Synthes · Class II

Cleared under the same submission

K113387 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Citieffe

Sources (1)

FDA UDI d5143dd2-fd8b-4dca-b9ea-813463598c9e 38 fields · synced Jun 8, 2026