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restor3d Veritas rTSA Instrumentation

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name
restor3d Veritas rTSA Instrumentation FDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Device Name
Glenosphere trial kit - (1) Ø40+0 (1) Ø40+4 FDA UDI
Model / Reference
4520-1003 FDA UDI
Description
Glenosphere trial kit - (1) Ø40+0 (1) Ø40+4 FDA UDI

Identifiers

Primary DI / UDI-DI
00840097516080 FDA UDI
510(k) Number
K243643 FDA UDI
FDA Product Code
PHX FDA UDI
KWS FDA UDI
GMDN Term
Surgical implant/trial-implant/sizer holder, 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical implant/trial-implant/sizer holder, 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 Surgical implant/trial-implant/sizer holder, single-use.

Cleared under the same submission

K243643 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Restor3D

Sources (1)

  • FDA UDI 84546ccb-e508-450f-85db-b707e390ae47 34 fields · synced Jun 8, 2026