restor3d Veritas rTSA Instrumentation

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name: restor3d Veritas rTSA Instrumentation FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: Glenoid pin kit - (1) Ø2.0x 7 (1) Ø2.8x 8 FDA UDI
Model / Reference: 4510-1001 FDA UDI
Description: Glenoid pin kit - (1) Ø2.0x 7 (1) Ø2.8x 8 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097516042 FDA UDI
510(k) Number: K243643 FDA UDI
FDA Product Code: PHX FDA UDI
KWS FDA UDI
GMDN Term: Orthopaedic guidewire, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Category: Orthopaedic guidewire, single-use

restor3d Veritas rTSA Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic guidewire, single-use.

OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I

Cleared under the same submission

K243643 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

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Manufacturer

Manufacturer: Restor3D

Sources (1)

FDA UDI ee0418ac-a9fe-47a6-8964-79260dc00007 34 fields · synced May 30, 2026