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510(k) K924657

TRUE/FLEX METATARSAL RODS by Applied Osteo Systems, Inc. — Product Code KTW

K924657 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "TRUE/FLEX METATARSAL RODS". The FDA issued a decision of Substantially Equivalent on November 24, 1992. The device falls under product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component), a Class II device regulated under 21 CFR 888.3030. Applied Osteo Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1992
Date Received
September 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Applied Osteo Systems, Inc.

  • K935383 — FEMROD AND FEMROD RECON INSERT (March 21, 1995)
  • K933995 — TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION (January 27, 1995)
  • K944501 — TRUE/FLEX INTRAMEDULLARY ROD END-CAP (November 28, 1994)
  • K941048 — TRUE/LOK MONOLATERAL/BILATERAL FIXATOR (October 3, 1994)
  • K943160 — INTERFERENCE SCREW (September 30, 1994)
  • K932853 — PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS (February 22, 1994)
  • K934148 — TRUE/FLEX CLAVICLE RODS (February 22, 1994)
  • K931578 — TEXAS SCOTTISH RITE EASY/LOCK FIXATOR (February 22, 1994)
  • K926465 — FEMORAL INTRAMEDULLARY RODS (August 25, 1993)
  • K924656 — TRUE/ FLEX FIBULA RODS (November 24, 1992)

Other clearances for product code KTW

  • K182285 — PK High Tibial Osteotomy Correction System (June 20, 2019)
  • K171606 — AOS Anterolateral Proximal Humeral Plate (June 22, 2017)
  • K170693 — Phantom Small Bone Intramedullary Nail System (June 19, 2017)
  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (September 20, 2012)
  • K080590 — AOS PROXIMAL HUMERAL PLATE (May 6, 2008)
  • K080109 — SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (March 20, 2008)
  • K062920 — ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (November 13, 2006)
  • K023360 — LEFORTE SYSTEM BONE PLATE (October 25, 2002)
  • K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES (June 24, 2002)

FDA data resources