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510(k) K963396

BIOSPHERE SUTURE ANCHOR by Instrument Makar, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
August 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K930980 — INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW (February 10, 1994)
  • K923841 — BONE SCREWS (October 27, 1993)

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