Medical Device Manufacturer · US , Mchenry , IL

Holter-Hausner Intl. - FDA 510(k) Cleared Devices

42 submissions · 38 cleared · Since 1978

42

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Holter-Hausner Intl. Orthopedic ✕

8 devices

1-8 of 8

Cleared Sep 28, 1987

H-H HUNTER ACTIVE TENDON IMPLANT PC

Orthopedic · 104d

Cleared Sep 28, 1987

H-H HUNTER ACTIVE TENDON IMPLANT DC

Orthopedic · 104d

Cleared Sep 28, 1987

H-H HUNTER ACTIVE TENDON IMPLANT BC

Orthopedic · 104d

Cleared Oct 16, 1985

H-H HUNTER TENDON ROD

Orthopedic · 62d

Cleared Sep 30, 1985

H-H HUNTER ACTIVE TENDON IMPLANT

Orthopedic · 46d

Cleared Apr 17, 1985

H-H TENDEON IMPLANT

Orthopedic · 260d

Cleared Dec 04, 1978

TENDON ROD MODEL OR41PO3-6

Orthopedic · 17d

Cleared Mar 17, 1978

PASSIVE TENDON IMPLANT

Orthopedic · 21d