Home / 510(k) Clearances / K952168

510(k) K952168

TITANIUM MANDIBULAR FRACTURE SYSTEM by Medicon, Inc. — Product Code JEY

K952168 is an FDA 510(k) premarket notification submitted by Medicon, Inc. for the device "TITANIUM MANDIBULAR FRACTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 22, 1995. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Medicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1995
Date Received
May 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Medicon, Inc.

  • K962087 — SERVOTRONIC EC100 SYSTEM (April 23, 1997)
  • K850855 — TENS GB1001 DEVICE (January 9, 1986)
  • K850852 — INFRARAX DEVICE (August 21, 1985)
  • K844702 — GAUZE ASORBABLE (April 1, 1985)
  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)
  • K844704 — CAPS (O.R. NURSE, SURGICAL) (January 10, 1985)
  • K840034 — VACUUM STRETCHER IMMOBILIZER (February 27, 1984)

Other clearances for product code JEY

  • K252246 — Leforte MMF System (April 2, 2026)
  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233874 — tmCMF Solution (July 11, 2024)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (April 30, 2024)
  • K232350 — Stryker Facial iD System (January 13, 2024)
  • K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (September 26, 2023)
  • K230733 — Stryker Resorbable Fixation System (August 5, 2023)

FDA data resources