PASSIVE TENDON IMPLANT— 510(k) K780320

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K780320 for PASSIVE TENDON IMPLANT, Substantially Equivalent on 1978-03-17. Applicant: Holter-Hausner Intl.. Device class: 2.

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code HXA
Device class: Class 2
Regulation: 21 CFR 888.3025
Advisory panel: Orthopedic
Date received: 1978-02-24
Decision date: 1978-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXA

K243477 — Universal Tendon Spacer2025-01-10
K000019 — SINGLE SIZE TENDON SPACER2000-03-29
K973385 — OVAL SHAPES1997-12-05
K964359 — AVANTA ORTHOPAEDICS TENDON SPACER1997-03-25
K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES1993-12-30

More clearances from Holter-Hausner Intl.

K875287 — H-H FLUSHING RESERVOIR1988-07-14
K874508 — H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG1988-01-19
K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC1987-09-28
K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC1987-09-28
K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC1987-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.