Zimmer Patient Specific Instrument

FDA UDI

Class II (US FDA UDI)

by Orthosoft Inc

Identity

Trade Name: Zimmer Patient Specific Instrument FDA UDI
Generic Name: CAD/CAM software FDA UDI
Model / Reference: 803.3020 FDA UDI

Identifiers

Catalog Number: 803.3020 FDA UDI
Primary DI / UDI-DI: 00889024211629 FDA UDI
510(k) Number: K131409 FDA UDI
FDA Product Code: OOG FDA UDI
MBH FDA UDI
JWH FDA UDI
GMDN Term: CAD/CAM software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Category: CAD/CAM software

Zimmer Patient Specific Instrument by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as CAD/CAM software.

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CEREC Guide — Sirona Dental Systems GmbH · Class I
Mimics — Materialise NV · Class II
ProPlan CMF — Materialise NV · Class I
CEREC Guide — Sirona Dental Systems GmbH · Class I

Cleared under the same submission

K131409 also covers:

PSI Knee — Orthosoft Inc

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: Orthosoft Inc

Sources (1)

FDA UDI 211d15c2-d534-4cd4-9ae9-e82468ea9008 35 fields · synced Jun 8, 2026