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510(k) K930980

INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW by Instrument Makar, Inc. — Product Code HWC

Clearance Details

Decision
SN ()
Decision Date
February 10, 1994
Date Received
February 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR (July 9, 1996)
  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K923841 — BONE SCREWS (October 27, 1993)

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