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510(k) K984117

INNOVA TELESCOPIC DISTRACTOR by Innova Corp. — Product Code MQN

K984117 is an FDA 510(k) premarket notification submitted by Innova Corp. for the device "INNOVA TELESCOPIC DISTRACTOR". The FDA issued a decision of Substantially Equivalent on February 10, 1999. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. Innova Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1999
Date Received
November 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Mandibular Fixator And/Or Distractor
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Innova Corp.

  • K040714 — HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT (April 9, 2004)
  • K971196 — ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (May 8, 1997)
  • K952434 — ENDOPORE DENTAL IMPLANT ABUTMENTS (July 19, 1995)
  • K926354 — ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (February 13, 1995)
  • K915361 — THE BODY BUGGY (December 20, 1991)

Other clearances for product code MQN

  • K220050 — KLS Martin IPS Distraction (August 11, 2022)
  • K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional (March 13, 2019)
  • K181504 — Stryker Pediatric Mandibular Distractor 2 (September 11, 2018)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K161470 — Internal Distraction - Sterile (December 1, 2016)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K133398 — STRYKER PEDIATRIC MANDIBLE DISTRACTOR (March 20, 2014)
  • K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM (August 23, 2012)
  • K080458 — MIS CREST WIDENER (December 17, 2008)
  • K080542 — DISTRAX (December 15, 2008)

FDA data resources