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Kampner Hinged Toe Prosthesis

by Biomedics 510(k)

Active United States

510(k) K801345

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801345 Date8 Jul 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KWH
Device Class
Class II
Regulation
21 CFR Part 888.3720
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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