Home / 510(k) Clearances / K855030

510(k) K855030

CHAMPY BONE PLATES & BONE SCREWS by Advanced Biosearch Assn. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1986
Date Received
December 16, 1985
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 Advanced Biosearch Assn.

  • K905514 — AUTOGENESIS(TM) AUTOMATOR (April 2, 1991)
  • K883888 — CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (December 12, 1988)
  • K854770 — MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM (February 11, 1986)
  • K855031 — MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P (January 21, 1986)
  • K853916 — P.M. HIP-FEMORAL PROSTHESIS (December 27, 1985)
  • K852839 — FREEMAN HIP (October 29, 1985)
  • K853418 — SAFTI-BRACELET (September 20, 1985)
  • K852517 — CLS HIP PROSTHESIS (September 18, 1985)
  • K852699 — FREEMAN ACETABULAR CUP (September 5, 1985)
  • K850773 — PM CEMENTLESS SCREW-IN ACETABULAR CUP (May 2, 1985)

Other clearances for product code JEY

  • 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)
  • K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate (December 9, 2022)