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510(k) K013786

DRG ORTHOHEX SS BONE SCREW by Doctor'S Research Group, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2001
Date Received
November 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Doctor'S Research Group, Inc.

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  • K012535 — DRG DISPOSABLE VAGINAL SPECULUM (March 1, 2002)
  • K012003 — DRG REACTION CHAMBER/SAFETY TIP (February 12, 2002)
  • K011736 — DRG QUICKMIX (January 30, 2002)
  • K002047 — DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT (November 22, 2000)
  • K991714 — DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 (December 10, 1999)
  • K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 (September 14, 1999)
  • K990920 — DRG TITANIUM BONE PLATE (June 10, 1999)
  • K981881 — DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRIL (December 2, 1998)

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