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510(k) K140414

IMBIBE NEEDLE by Orthovita, Inc. — Product Code LXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2014
Date Received
February 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K933772 — PUNCH SURGICAL (February 1, 1994)