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510(k) K221943

EmbedMed by 3D Lifeprints UK , Ltd. — Product Code PBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2023
Date Received
July 5, 2022
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.

Other clearances by 3D Lifeprints UK , Ltd.

  • K220366 — EmbedMed (September 30, 2022)

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