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510(k) K943548

BIOABSORBABLE INTERFERENCE SCREW by Acufex Microsurgical, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1995
Date Received
July 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Acufex Microsurgical, Inc.

  • K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS (July 10, 1996)
  • K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER (June 21, 1996)
  • K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW (February 15, 1996)
  • K952535 — ACUFEX ENDOBUTTON TAPE (February 8, 1996)
  • K953276 — ACUFEX TAG DELIVERY SYSTEM (October 5, 1995)
  • K953459 — ACUFEX TAG ANCHOR (August 23, 1995)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • K944500 — ACUFEX PATELLAR BONE BLOCK SIZER (June 12, 1995)
  • K951859 — ACUFEX ENDOBUTTON PACK (June 9, 1995)
  • K946346 — ACUFEX TAG(R) BIOABSORBABLE ANCHORS (April 26, 1995)

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  • K242415 — TMC Compression Implant System (September 6, 2024)
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  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)