Knee Instruments

GUDID 07630542755095

SpheriKA Femoral Trial with Lugs S4L

Medacta International SA

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 07630542755095
• NIH Device Record Key: 43f19c6f-bc70-4c8b-b932-0cc1c9e56aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knee Instruments
• Version Model Number: 02.12.10.3003
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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	07630542755095 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

[07630542755095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-11-07

On-Brand Devices [Knee Instruments]

• 07630971234840: Large tibial base plate impactor
• 07630971230668: Global Instrument Tibial palpator 8 mm MIS
• 07630971230651: Global Instrument Tibial Palpator 2mm MIS
• 07630971230620: Cutting sizer
• 07630971216143: Reamer 28
• 07630971216136: Reamer 24
• 07630971216129: Reamer 20
• 07630971216112: Reamer guide 28 Evolis
• 07630971216105: Reamer guide 24
• 07630971216099: Reamer guide 20
• 07630971216037: Drilling guide
• 07630971216020: Superior insert for impaction
• 07630971216013: Inferior insert for patella clamp
• 07630971216006: Patella cutting guide Right
• 07630971215993: Patella cutting guide Left
• 07630971215979: chisel
• 07630971215948: Drill bit guide Ø10 mm
• 07630971215931: Puncher #5/6
• 07630971215924: Puncher #3/4
• 07630971215917: Puncher #1/2
• 07630971215894: Sliding handle
• 07630971215863: Femoral extractor
• 07630971215849: Impaction/extraction punch handle
• 07630971215214: Drill bit AO connection 10 mm
• 07630971215191: Drill bit AO connection 5 mm
• 07630971215177: Screwdriver 3.5 mm
• 07630971215160: Assembly posterior stabilized cam insert
• 07630971215153: Cam for postero stabilized trial femur
• 07630971215146: Trial base plate handle
• 07630971215115: Pin 3.2 L 55 mm
• 07630971215108: Pin 2.7 L 30 mm
• 07630971215054: Drill bit 2.7 mm
• 07630971215047: Femoral Intramedullary rod 8 mm
• 07630971215030: Trial inset patella 28
• 07630971215023: Trial inset patella 24
• 07630971215016: Trial inset patella 20
• 07630971215009: Trial resurfacing patella 39
• 07630971214996: Trial resurfacing patella 36
• 07630971214989: Trial resurfacing patella 33
• 07630971214972: Trial resurfacing patella 30
• 07630971214965: Trial insert # 6/19 mm
• 07630971214958: Trial insert # 6/16 mm
• 07630971214941: Trial insert # 6/13 mm
• 07630971214934: Trial insert # 6/11 mm
• 07630971214118: Correc.Distal MIS Cutting Guide +2°Var/Valg Unslot
• 07630971214071: MIS - Femoral Cutting Guide 4/1 - #6
• 07630971214064: MIS - Femoral Cutting Guide 4/1 - #5
• 07630971214057: MIS - Femoral Cutting Guide 4/1 - #4
• 07630971214040: MIS - Femoral Cutting Guide 4/1 - #3
• 07630971214033: MIS - Femoral Cutting Guide 4/1 - #2