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ROSA® Knee

FDA UDI

Class II (US FDA UDI)

by Orthosoft Inc

Identity

Trade Name
ROSA® Knee FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Model / Reference
20-8020-196-00 FDA UDI

Identifiers

Catalog Number
20-8020-196-00 FDA UDI
Primary DI / UDI-DI
00887868552175 FDA UDI
510(k) Number
K221928 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

ROSA® Knee by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthosoft Inc

Sources (1)

  • FDA UDI f353b42f-447c-4f09-9279-9553e80b848d 36 fields · synced Jun 8, 2026