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510(k) K970378

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

K970378 is an FDA 510(k) premarket notification submitted by Implant Resource, Inc. for the device "STRYKER 2115 REPLACEMENT BATTERY (2115)". The FDA issued a decision of Substantially Equivalent on April 30, 1997. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Implant Resource, Inc. has at least 1 other 510(k) clearance on record.

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)

Other clearances for product code KIJ

  • K163308 — SMARTO (December 27, 2016)
  • K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT (November 6, 2012)
  • K101563 — SMARTO (December 17, 2010)
  • K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (September 4, 1997)
  • K960711 — ACUMED BONE GRAFT SYSTEM (May 7, 1996)
  • K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (May 17, 1995)
  • 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)

FDA data resources