Home / 510(k) Clearances / K922211

510(k) K922211

OSTEOMED GREAT TOE SYSTEM by Osteomed Corp. — Product Code LZJ

K922211 is an FDA 510(k) premarket notification submitted by Osteomed Corp. for the device "OSTEOMED GREAT TOE SYSTEM". The FDA issued a decision of SN on November 9, 1993. The device falls under product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained), a Class U device. Osteomed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 9, 1993
Date Received
May 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Osteomed Corp.

  • K212570 — OsteoPlan System (February 11, 2022)
  • K203479 — ExtremiLOCK Lateral Ankle Fusion Plates (February 24, 2021)
  • K202105 — OsteoMed ExtremiFix Mini & Small System Tray (October 29, 2020)
  • K202680 — OsteoMed ExtremiFix Mini & Small Cannulated Screw System (October 15, 2020)
  • K173391 — OsteoMed QuickFix Hybrid MMF Sterilization Tray (May 10, 2018)
  • K162542 — OsteoMed PINNACLE Driver (May 19, 2017)
  • K163303 — OsteoMed ExtremiFix Mid and Large Screw System (April 4, 2017)
  • K162544 — OsteoMed PINNACLE Driver (April 4, 2017)
  • K161041 — OsteoMed ExtremiLOCK Wrist Plating System (May 19, 2016)
  • K152145 — OsteoMed ExtremiLOCK Wrist Plating System (December 21, 2015)

Other clearances for product code LZJ

  • K132496 — ARTHROSURFACE TOEMOTION (February 26, 2014)
  • K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (December 21, 2010)
  • K072251 — MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (May 8, 2008)
  • K950864 — GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (July 31, 1995)
  • K941650 — TOTAL TOE SYSTEM II (December 19, 1994)
  • K924724 — KINETIK GREAT TOE SYSTEM (January 5, 1994)
  • K920446 — TOTAL TOE SYSTEM (March 22, 1993)
  • K920667 — GREAT TOE IMPLANT (June 19, 1992)
  • K911552 — ANATOMIC TOE SYSTEM (June 28, 1991)
  • K884561 — KOENIG TOTAL TOE IMPLANT (January 24, 1989)

FDA data resources