Knee Plane Tool - Cb Adapter

FDA UDI

Class II (US FDA UDI)

by Brainlab SE

Identity

Trade Name: Knee Plane Tool - Cb Adapter FDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Model / Reference: 53202 FDA UDI

Identifiers

Catalog Number: 53202 FDA UDI
Primary DI / UDI-DI: 04056481005610 FDA UDI
510(k) Number: K102990 FDA UDI
K220652 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Robotic surgical navigation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Knee Plane Tool - Cb Adapter by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102990 also covers:

Clearlens — Smith & Nephew, Inc.
Clearlens — Smith & Nephew, 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: Brainlab SE

Sources (1)

FDA UDI c5ac1585-1888-4560-a01b-9b0bab8d3134 36 fields · synced Jun 1, 2026