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510(k) K042434

MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 by NOUVAG AG — Product Code DZI

K042434 is an FDA 510(k) premarket notification submitted by NOUVAG AG for the device "MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55". The FDA issued a decision of Substantially Equivalent on November 3, 2004. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. NOUVAG AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2004
Date Received
September 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by NOUVAG AG

  • K254135 — LipoSurg ARTIST (September 5, 2026)
  • K080365 — MORCE POWER PLUS AND VARIOCARVE MORCELLATOR (June 29, 2009)
  • K081191 — TCM ENDO 20 (August 7, 2008)
  • K071588 — DISPENSER DP 20 (November 26, 2007)
  • K042822 — TCM ENDO V, MODEL 1534 (December 22, 2004)
  • K042943 — NOUVAG AG - VACUSON 40 AND VACUSON 60 (December 17, 2004)
  • K022505 — CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, (October 1, 2003)
  • K013185 — TCM ENDO III (November 28, 2001)
  • K000710 — MD 10, SEM, SM 12, CBM (May 11, 2000)
  • K981679 — TCM 3000 AND TCM ENDO (February 9, 1999)

Other clearances for product code DZI

  • K253655 — Angled Screwdriver MED (M-SD090) (July 31, 2026)
  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 2024)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)

FDA data resources