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510(k) K102601

ORTHOFLEX ROD by Ortho-Pro, LLC — Product Code KWH

K102601 is an FDA 510(k) premarket notification submitted by Ortho-Pro, LLC for the device "ORTHOFLEX ROD". The FDA issued a decision of Substantially Equivalent on January 14, 2011. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Ortho-Pro, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2011
Date Received
September 9, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3720
Review Panel
OR
Submission Type

Other clearances by Ortho-Pro, LLC

  • K094037 — TC PLATING SYSTEM (March 10, 2010)
  • K042310 — ORTHO-PRO CANNULATED BONE SCREWS (September 16, 2004)
  • K032682 — STS SCREW (October 22, 2003)

Other clearances for product code KWH

  • K191966 — NewPrim System (February 13, 2020)
  • K190136 — Fusion Silastic System (October 21, 2019)
  • K173491 — RTS Lesser MTP Implant System (February 23, 2018)
  • K153609 — RTS Flexible 1 MPJ Implant w/Grommets (September 8, 2016)
  • K023531 — LESSER METATARSAL PHALANGEAL JOINT IMPLANT (January 17, 2003)
  • K022887 — INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (November 26, 2002)
  • K022886 — METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (November 25, 2002)
  • K023562 — MODIFICATION TO CLASSIC GREAT TOE IMPLANT (November 13, 2002)
  • K023086 — CLASSIC GREAT TOE IMPLANT (October 4, 2002)
  • K994326 — ASCENT KNEE SYSTEM (January 7, 2000)

FDA data resources