Apollo Knee COR.ST.0001

GUDID 05056139245831

Apollo Station (US)

CORIN LTD

Robotic surgical arm system

• Primary Device ID: 05056139245831
• NIH Device Record Key: e8825072-15c1-4cdb-aaef-4d400a6f0b61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Knee
• Version Model Number: COR.ST.0001
• Catalog Number: COR.ST.0001
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056139245831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231172

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [Apollo Knee]

• 05056139246791: Apollo BalanceBot Cable
• 05056139246784: Apollo Robot Cable
• 05056139246036: Station Power Cable
• 05056139246029: Camera Assembly ST
• 05056139246012: Camera Assembly VT
• 05056139246005: Apollo Station (EU)
• 05056139245862: ApolloKnee Software
• 05056139245831: Apollo Station (US)
• 05056139245824: BalanceBot
• 05056139245763: Apollo Robot Enclosure Lid
• 05056139245756: Apollo Robot Enclosure Body
• 05056139245855: Tibial Cutting Guide Rail
• 05056139245749: V-Array
• 05056139245732: Tibial Cutting Guide - Right
• 05056139245725: Tibial Cutting Guide - Left
• 05056139245701: Femoral Sawing Guide
• 05056139245169: P-Array
• 05056139245152: G-Array
• 05056139244964: F-Array
• 05056139244957: T-Array
• 05056139244919: BalanceBot Tibial Tray, Size Small Right
• 05056139244926: Apollo BalanceBot Tibial Tray Trial Assembly - Small Left
• 05056139250651: Apollo Robot Extended Enclosure Body
• 05056139250644: ApolloKnee Tracker and Pin Kit
• 05056139249518: Sawing guide with calibration track - Extended
• 05056139246777: Cancellous bone screw 5.5mm x 93mm
• 05056139246760: Cancellous bone screw 5.5mm x 73mm
• 05056139246753: Cortical bone Screw 3.2mm x 110mm
• 05056139246746: Cortical bone Screw 3.2mm x 80mm
• 05056139246739: Cortical bone screw 4mm x 150mm
• 05056139246722: Cortical bone Screw 4mm x 120mm
• 05056139246715: Extended Femur Bone Fixation
• 05056139245817: Pre-Resection Tibial Fixation Block
• 05056139245800: Pre-Resection BalanceBot Paddles, Right B
• 05056139245794: Pre-Resection BalanceBot Paddles, Left B
• 05056139245787: Pre-Resection BalanceBot Paddles, Right A
• 05056139245770: Pre-Resection BalanceBot Paddles, Left A
• 05056139245718: Nano Block
• 05056139245374: Apollo Tracker Kit
• 05056139245176: BalanceBot Headed Pin
• 05056139245145: Femur Bone Fixation Base
• 05056139245077: Femoral Paddle, Large Left B
• 05056139245060: Femoral Paddle, Large Right B
• 05056139245053: Femoral Paddle, Large Left A
• 05056139245039: Femoral Paddle, Large Right A
• 05056139245022: Femoral Paddle, Small Left B
• 05056139245015: Femoral Paddle, Small Right B
• 05056139245008: Femoral Paddle, Small Left A
• 05056139244995: Femoral Paddle, Small Right A
• 05056139244988: Universal Reattachable Joint Ø6.9mm Adaptor