Laax, Inc.

FDA Regulatory Profile

Laax, Inc. appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1461-2015, Class I) was initiated on March 25, 2015. Its most recent 510(k) clearance was granted on May 18, 2011.

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1461-2015Class ITIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantablMarch 25, 2015
Z-1462-2015Class ITIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantablMarch 25, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K111064TIGERPAW SYSTEM IIMay 18, 2011
K101961TIGERPAW SYSTEMOctober 29, 2010