Medical Device Manufacturer · US , Greenwood , SC

Osteo AG - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1991

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osteo AG Orthopedic ✕

8 devices

1-8 of 8

Cleared Jun 30, 1994

OSTEO INTERLOCKING-COMPRESSION NAIL

Orthopedic · 357d

Cleared Jul 23, 1992

OSTEO KIRSCHNER WIRE

Orthopedic · 73d

Cleared Jul 23, 1992

OSTEO STEINMANN PIN

Orthopedic · 73d

Cleared Jul 23, 1992

OSTEO FEMORAL NAIL

Orthopedic · 73d

Cleared Jul 23, 1992

OSTEO TIBIA NAIL

Orthopedic · 73d

Cleared Apr 09, 1992

Orthopedic · 90d

Cleared Dec 30, 1991

OSTEO CERCLAGE WIRE

Orthopedic · 90d

Cleared Nov 07, 1991

OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR

Orthopedic · 90d