Home / 510(k) Clearances / K963026

510(k) K963026

TBD by Acu Med, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1996
Date Received
August 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Acu Med, Inc.

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  • K013616 — POLARUS CAP SCREW (December 19, 2001)
  • K012655 — CONGRUENT BONE PLATE SYSTEM (November 7, 2001)
  • K992525 — ACUMED MODULAR SHOULDER SYSTEM (February 4, 2000)
  • K993657 — ACUMED SUTURE ANCHOR (January 13, 2000)
  • K980103 — ACUMED SUTURE ANCHOR (March 16, 1998)
  • K965028 — ACUMED SUTURE WASHER (March 17, 1997)
  • K965029 — STABLELOC II EXTERNAL FIXATOR (February 19, 1997)
  • K964500 — ACUMED TENSION BAND PIN (December 9, 1996)
  • K963118 — EXTREMITY BONE SCREW (October 10, 1996)

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