Osteo Technology, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K926156REPLICA(TM) TOTAL HIP SYSTEMMarch 9, 1994
K922859ANATOMICAL TYPE KNEE SYSTEMSeptember 23, 1993
K922869TOTAL CONDYLAT TYPE KNEE SYSTEMJuly 13, 1993
K925447OTI ORTHOPEDIC WIRE SYSTEMJune 29, 1993
K926213MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEMJune 17, 1993
K922861BIOMETRIC SCREW FIXATION CUPMay 12, 1993
K922870THREE SPIKE CUPApril 8, 1993
K922682AMERICANA HIP PROTHESISMarch 16, 1993
K925301OTI ORTHOPEDIC FASTENER SYSTEMMarch 16, 1993
K922862CHARNLEY TYPE HIP PROTHESISFebruary 12, 1993
K922864MUELLER TYPE FEMORAL STEMFebruary 12, 1993
K922868THOMPSON TYPE HIP PROTHESISFebruary 12, 1993
K922863EUROSTEM HIP PROTHESIS SYSTEMFebruary 12, 1993
K922871UNIFIT FEMORAL STEMFebruary 12, 1993
K922860AUSTIN-MOORE TYPE HIP PROSTHESISFebruary 12, 1993
K922866OTI BONE PLUGFebruary 12, 1993
K922645LSF ANATOMIC CEMENTED HIPJanuary 7, 1993
K922865NEER TYPE SHOULDER PROSTHESIS SYSTEMDecember 10, 1992