FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

59 results for "Spine Wave, Inc."
49–59 of 59
Search insights Median review: 83d Cleared: 100% Top manufacturer: Spine Wave, Inc. Lead specialty: Orthopedic
Cleared Jun 04, 2010
MIS SYSTEM
K100605 · MNH
Spine Wave, Inc.
Orthopedic · 93d
Cleared Feb 12, 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · MNH
Spine Wave, Inc.
Orthopedic · 28d
Cleared Sep 03, 2009
STAXX XD SYSTEM
K090315 · MQP
Spine Wave, Inc.
Orthopedic · 206d
Cleared Jan 13, 2009
CAPSURE PS SYSTEM
K083743 · MNI
Spine Wave, Inc.
Orthopedic · 28d
Cleared Dec 11, 2008
CAPSURE(R) PS SYSTEM
K083353 · MNI
Spine Wave, Inc.
Orthopedic · 28d
Cleared May 12, 2008
CAPSURE PS (R) SPINE SYSTEM
K081228 · MNI
Spine Wave, Inc.
Orthopedic · 12d
Cleared Apr 13, 2007
MODIFICATION TO STAXX FX SYSTEM
K063606 · OBL
Spine Wave, Inc.
Orthopedic · 133d
Cleared Apr 05, 2007
CAPSURE PEDICLE SCREW SYSTEM
K070245 · MNI
Spine Wave, Inc.
Orthopedic · 70d
Cleared Jul 03, 2006
STAXX FX SYSTEM
K053336 · NDN
Spine Wave, Inc.
Orthopedic · 214d
Cleared Apr 27, 2006
STAXX XD SYSTEM
K052670 · MQP
Spine Wave, Inc.
Orthopedic · 212d
Cleared Jun 24, 2004
WAFER SYSTEM
K033303 · HRS
Spine Wave, Inc.
Orthopedic · 254d