510(k) K211076

Patient Specific Marking Guides by Additive Orthopaedics, LLC — Product Code PBF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 28, 2022
Date Received: April 12, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopaedic Surgical Planning And Instrument Guides
Device Class: Class II
Regulation Number: 888.3030
Review Panel: OR
Submission Type

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

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K170214 — Additive Orthopaedics Locking Lattice Plate (April 13, 2017)
K153207 — Additive Orthopaedics Bone Wedge System (September 7, 2016)
K160264 — Additive Orthopaedics Hammertoe Correction System (June 1, 2016)

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