Home / 510(k) Clearances / K915889

510(k) K915889

MITEK BONE ANCHOR, MODIFICATION by Mitek Surgical Products, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1992
Date Received
December 20, 1991
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 Mitek Surgical Products, Inc.

  • K953560 — MITEK THREADED ANCHOR (FASTIN) (January 31, 1996)
  • K953877 — MITEK GII ANCHOR (December 29, 1995)
  • K936311 — MITEK MINI ANCHOR (October 31, 1995)
  • K941599 — MITEK ABSORBABLE ANCHOR (October 24, 1995)
  • K944051 — ABSORBALBE ANCHOR (August 2, 1995)
  • K950070 — MITEK TOGGLE ANCHOR(TM) (May 22, 1995)
  • K944936 — MITEK G III ANCHOR, MITEK LS ANCHOR (March 24, 1995)
  • K945203 — MITEK THRADED ANCHOR (MTA) (March 6, 1995)
  • K934366 — MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER (October 7, 1994)
  • K931782 — MITEK GIII ANCHOR (July 22, 1994)

Other clearances for product code JDR

  • K250712 — Linkt Compression Staple System (May 14, 2025)
  • K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (April 11, 2025)
  • K243742 — Arthrex DynaNite Nitinol Staples (January 31, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • 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)