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510(k) K192768

Temporary Fixation Pins by Eisertech, LLC — Product Code JDW

K192768 is an FDA 510(k) premarket notification submitted by Eisertech, LLC for the device "Temporary Fixation Pins". The FDA issued a decision of Substantially Equivalent on December 26, 2019. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Eisertech, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2019
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Eisertech, LLC

  • K190565 — Cervical Plate (May 31, 2019)
  • K140348 — INTERBODY CAGE (April 23, 2015)
  • K142576 — Spinal System (February 26, 2015)
  • K122444 — CERVICAL CAGE (August 30, 2012)
  • K113170 — CERVICAL PLATE (April 6, 2012)
  • K113478 — PLIF CAGE (March 5, 2012)
  • K110915 — CERVICAL CAGE (July 22, 2011)

Other clearances for product code JDW

  • K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (February 10, 2026)
  • K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System (October 29, 2025)
  • K241357 — XT3 System (January 22, 2025)
  • K223112 — MAVERICK Mini External Fixation System (December 8, 2022)
  • K213874 — MAVERICK External Fixation System (February 11, 2022)
  • K211508 — Steinmann Pins and Kirschner Wires (October 5, 2021)
  • K210784 — Extended HA Half Pins (April 2, 2021)
  • K200933 — Syntec Non-Sterile Steinmann Pins System (May 5, 2020)
  • K191803 — Orthopedic Fixation Pin (April 14, 2020)
  • K182171 — SMV Scientific K-Wire and Pins (October 25, 2018)

FDA data resources