ClearanceBrief
510(k) K092815 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar

S-LIF INTERVERTEBRAL BODY FUSION DEVICE

ApplicantSpinefrontier, Inc., Beverly MA, US
DecisionSubstantially Equivalent, Jun 30, 2010
ReceivedSep 14, 2009
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K092815

DateFirm and productCodeLinked 510(k)
May 7, 2014SpineFrontier, Inc.
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, I
Terminated		 MAXNone listed
Nov 14, 2013SpineFrontier, Inc.
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varie
Terminated		 LXHNone listed
Aug 8, 2013SpineFrontier, Inc.
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal
Terminated		 MDMNone listed
Jul 5, 2013SpineFrontier, Inc.
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body
Terminated		 LXHNone listed
Jul 5, 2013SpineFrontier, Inc.
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants
Terminated		 FSMNone listed
Nov 21, 2012SpineFrontier, Inc.
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, witho
Terminated		 MAXNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.