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510(k) K943071

THE TITANIUM FIXATION SYSTEM by Biomedics — Product Code JEY

K943071 is an FDA 510(k) premarket notification submitted by Biomedics for the device "THE TITANIUM FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 6, 1995. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Biomedics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1995
Date Received
June 28, 1994
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 Biomedics

  • K992330 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (November 23, 1999)
  • K984583 — THE BIOPLATE SHUNT CONNECTOR (March 15, 1999)
  • K980983 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (June 9, 1998)
  • K972463 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (September 25, 1997)
  • K961976 — THE BIOPLATE FIXATION SYSTEM (August 16, 1996)
  • K953273 — BIOPLATE RIGID FIXATION BONE PLATING SYSTEM (September 29, 1995)
  • K844787 — BIOMETRIC TOTAL HIP SYSTEM (April 19, 1985)
  • K842687 — BIOMEDICS BLADDER SCANNER (April 8, 1985)
  • K801345 — KAMPNER HINGED TOE PROSTHESIS (July 8, 1980)

Other clearances for product code JEY

  • K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions (August 17, 2026)
  • K253206 — METICULY Patient-specific CMF solution (July 25, 2026)
  • 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)

FDA data resources