Home / 510(k) Clearances / K964953

510(k) K964953

IN-TAC BONE ANCHOR SYSTEM by Influence, Inc. — Product Code HXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1997
Date Received
December 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple Driver
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Influence, Inc.

  • K981677 — REPOSE BONE SCREW SYSTEM (August 27, 1999)
  • K991792 — CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE (August 12, 1999)
  • K992277 — STAPLETAC BONE ANCHOR SYSTEM (July 30, 1999)
  • K991122 — CRYO-MONO CRYOGRNIC SYSTEM (July 1, 1999)
  • K990160 — MICROTAC-BONE ANCHOR SYSTEM (February 16, 1999)
  • K990095 — STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (February 1, 1999)
  • K983325 — IN-PROBE II URODYNAMIC SYSTEM (November 24, 1998)
  • K982155 — SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM (August 31, 1998)
  • K981631 — INFLUENCE CLIP SYSTEM (July 28, 1998)
  • K980482 — TRIANGLE SLING (March 27, 1998)

Other clearances for product code HXJ

  • K962372 — UROTAC BONE ANCHOR INSERTER (August 19, 1996)
  • K930205 — ELECTRIC WIRE DRIVER, MODEL 2640E (August 2, 1993)
  • K834515 — FIXATION STAPLE KIT - DLIDE HAMMER (April 23, 1984)
  • K830456 — STAPLE INSERTER-EXTRACTOR FOR ARTHROS (March 9, 1983)
  • K830255 — OSTEOTOMY BONE STAPLE (March 9, 1983)