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510(k) K180191

SuperBall Meniscal Repair System by Arcuro Medical , Ltd. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2018
Date Received
January 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Arcuro Medical , Ltd.

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  • K223500 — SuperBall Meniscal Repair System (August 10, 2023)

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