Skip to content

Exoshape (Tm) Interference Fixation Device Model 1100-00-Xxxx (Varies by Size)

by Medshape Solutions 510(k)

Active United States

510(k) K111471

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK111471 Date10 Jun 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1276-2013 FDA Class II initiated 4 Apr 2013

    Expiration date on the patient label and date on the product carton were not the same.

Specification

510(k)

510(k) Number
FDA Product Code
MBI
FDA applicant
Medshape Solutions, Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Medshape Solutions