Medical Device Manufacturer · US , Vista , CA

Seaspine, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 2005
27
Total
27
Cleared
0
Denied

Seaspine, Inc. has 27 FDA 510(k) cleared orthopedic devices. Based in Vista, US.

Last cleared in 2023. Active since 2005.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Seaspine, Inc.
27 devices
1-12 of 27
Cleared Aug 03, 2023
NorthStar OCT System
K231654 · NKG
Orthopedic · 58d
Cleared Mar 23, 2015
Integra Laminoplasty System
K150469 · NQW
Orthopedic · 28d
Cleared Dec 18, 2014
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)...
K142488 · MAX
Orthopedic · 105d
Cleared May 01, 2014
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · MAX
Orthopedic · 175d
Cleared Nov 18, 2013
INTEGRA FACET FIXATION SYSTEM
K132859 · MRW
Orthopedic · 67d
Cleared Sep 04, 2013
INTEGRA INTERSPINOUS PROCESS SYSTEM
K121924 · PEK
Orthopedic · 429d
Cleared May 09, 2013
INTEGRA LAMINOPLASTY SYSTEM
K130830 · NQW
Orthopedic · 44d
Cleared Dec 12, 2012
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571 · NKB
Orthopedic · 111d
Cleared Jan 25, 2012
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K112206 · KWQ
Orthopedic · 177d
Cleared Dec 28, 2011
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · ETN
Ear, Nose, Throat · 196d
Cleared May 12, 2011
SEASPINE SPACER SYSTEM
K102026 · MAX
Orthopedic · 297d
Cleared Jan 27, 2011
REDONDO-L
K103297 · MAX
Orthopedic · 80d
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