Home / 510(k) Clearances / K013888

510(k) K013888

FIXATION (STEINMANN) PINS by Miltex, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2002
Date Received
November 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Miltex, Inc.

  • K101653 — MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES (August 2, 2010)
  • K092855 — MILTEX MEMBRANE TACK KIT (December 29, 2009)
  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K072563 — MILTEX RIGID CONTAINER SYSTEMS (February 12, 2008)
  • K061033 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) (December 12, 2006)
  • K052018 — MILTEX LIGATING CLIP (November 4, 2005)
  • K050570 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM (July 25, 2005)
  • K043013 — MILTEX LAPAROSCOPIC INSTRUMENTS (March 4, 2005)
  • K954185 — RE-BAG MULTI-USE POUCH, LARGE & SMALL (December 4, 1995)
  • K823319 — DENTAL INSTRUMENTS - SCALERS (November 24, 1982)

Other clearances for product code HTY

  • K253325 — ZipToe™ Hammertoe Fusion System (December 29, 2025)
  • K252657 — Impact PEEK Union Nail System (September 19, 2025)
  • K250315 — RONAVIS – FX (FX-001) (August 1, 2025)
  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K250646 — Impact PEEK Union Nail System (June 11, 2025)
  • K241014 — Biomet Kirschner Wires (K-Wires) (May 22, 2024)
  • K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm (December 1, 2023)
  • K231147 — Hammerdesis™ Interphalangeal Fusion System (September 14, 2023)
  • K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail (September 13, 2023)
  • K231905 — Electro-Spec Steri-Caps (August 14, 2023)