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510(k) K780645

HMD-2000 BATTERY-POWERED MINI-DRILL, THE by Medishield, Inc. — Product Code KIJ

K780645 is an FDA 510(k) premarket notification submitted by Medishield, Inc. for the device "HMD-2000 BATTERY-POWERED MINI-DRILL, THE". The FDA issued a decision of Substantially Equivalent on May 3, 1978. 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. Medishield, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
April 17, 1978
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 Medishield, Inc.

  • K781103 — SPECTRASCAN (September 27, 1978)
  • K780646 — AIR-PWOERED COLDRILL (April 28, 1978)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K770161 — MICROFENESTRATED HIP REPLACEMENT COMPON. (January 26, 1977)
  • K761020 — ANKLE (FREEMAN-SWANSON) (November 23, 1976)
  • K761021 — ANKLE INSTRUMENTS (FREEMAN-SWANSON) (November 23, 1976)
  • K760668 — SELECTATEC SYSTEM (September 27, 1976)

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)
  • K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115) (April 30, 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)

FDA data resources