Apollo Knee

FDA UDI

Class II (US FDA UDI)

by Corin Ltd

Identity

Trade Name: Apollo Knee FDA UDI
Generic Name: Robotic surgical arm system FDA UDI
Device Name: Pre-Resection BalanceBot Paddles, Left A FDA UDI
Model / Reference: TKR.BB.1100 FDA UDI
Description: Pre-Resection BalanceBot Paddles, Left A FDA UDI

Identifiers

Primary DI / UDI-DI: 05056139245770 FDA UDI
510(k) Number: K231172 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Robotic surgical arm system 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

FDA UDI

Single Use

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Robotic surgical arm system

Apollo Knee by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical arm system.

daVinci Xi — Intuitive Surgical, Inc. · Class II
SHURUI Large Tissue Forceps — Beijing Surgerii Robotics Company Limited · Class IIb
FLEX — Medrobotics Corporation · Class II
Flex — Medrobotics Corporation · Class II
Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
FLEX — Medrobotics Corporation · Class II
Senhance — Asensus Surgical, Inc. · Class II
ARTAS System — Venus Concept Inc. · Class II

Cleared under the same submission

K231172 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: Corin Ltd

Sources (1)

FDA UDI 7093dd72-765e-4a34-898d-b6052b55f38f 35 fields · synced May 30, 2026