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510(k) K970378

STRYKER 2115 REPLACEMENT BATTERY (2115) by Implant Resource, Inc. — Product Code KIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1997
Date Received
January 31, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Implant Resource, Inc.

  • K002125 — PINS AND WIRES (October 11, 2000)

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  • K944488 — S & S ORTHOPEDIC WIRE DRIVER 701 (March 2, 1995)
  • K941285 — ARTHREX GRAFT HARVESTING KIT (November 14, 1994)
  • K933101 — THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (November 7, 1994)
  • K933337 — R AND D BATTERY REPLACEMENT (April 5, 1994)