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SPINEFRONTIER, INC.

Last updated May 24, 2026

Information

Country: US
Address: —
Website: spinefrontier.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(866)914-7717
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 002003243

Catalogue (3161)

Page 1 of 64

Device	Model / Reference	Registries	Class	Status
PedFuse®	01-80046-30	FDA UDI	Class II	Active
PedFuse®	01-80017-50	FDA UDI	Class II	Active
S-Lift®	IM50001-44	FDA UDI	Class II	Active
S-Lift®	01-50119-1058S	FDA UDI	Class II	Active
S-Lift®	01-50119-0862S	FDA UDI	Class II	Active
PedFuse®	01-80139-20R	FDA UDI	Class II	Active
InSpan®	01-61002-1039	FDA UDI	Class II	Active
FacetFuse®	01-00009-SW5535	FDA UDI	U	Active
A-CIFT® SoloFuse®	01-32005-14	FDA UDI	Class II	Active
A-CIFT® SoloFuse®	11-32103	FDA UDI	Class II	Active
PedFuse®	01-80182-45	FDA UDI	Class II	Active
PedFuse	01-80047-40	FDA UDI	Class II	Active
PedFuse	01-80137-30	FDA UDI	Class II	Active
SacroFuse	01-42401-70	FDA UDI	Class II	Active
PedFuse®	IM80024-11	FDA UDI	Class II	Active
PedFuse®	01-80135-50	FDA UDI	Class II	Active
S-Lift®	IM50052-12	FDA UDI	Class II	Active
S-Lift®	IM50001-03	FDA UDI	Class II	Active
PedFuse®	IM80021-04	FDA UDI	Class II	Active
PedFuse®	01-80133-45R	FDA UDI	Class II	Active
InSpan®	IM61002-14	FDA UDI	Class II	Active
FacetFuse®	01-00009-SW5025	FDA UDI	U	Active
PedFuse	01-80164-5535	FDA UDI	Class II	Active
PedFuse®	01-80146-50R	FDA UDI	Class II	Active
PedFuse®	01-80147-65R	FDA UDI	Class II	Active
Indus®	01-71007-89	FDA UDI	Class II	Active
P-Lift®	01-06020-10	FDA UDI	Class II	Active
PedFuse®	01-80133-35R	FDA UDI	Class II	Active
PedFuse®	01-80128-75	FDA UDI	Class II	Active
Indus	01-71015-89	FDA UDI	Class II	Active
PedFuse®	01-80119-65	FDA UDI	Class II	Active
Arena-C®	11-72034-08	FDA UDI	Class II	Active
FacetFuse®	01-00007-SW4560	FDA UDI	U	Active
S-Lift®	IM50053-02	FDA UDI	Class II	Active
PedFuse®	01-80118-30	FDA UDI	Class II	Active
PedFuse®	01-80076-30	FDA UDI	Class II	Active
Tilt®	01-04022-3810	FDA UDI	Class II	Active
T-Lift®	SI02861-05	FDA UDI	Class II	Active
PedFuse®	01-80135-50R	FDA UDI	Class II	Active
S-Lift®	IM50052-13	FDA UDI	Class II	Active
S-Lift®	IM50001-04	FDA UDI	Class II	Active
T-Lift®	01-05001-08	FDA UDI	Class II	Active
InSpan®	IM61000-22	FDA UDI	Class II	Active
S-Lift®	11-50108-10	FDA UDI	Class II	Active
PedFuse®	01-80130-30	FDA UDI	Class II	Active
S-Lift®	01-50035-1638L	FDA UDI	Class II	Active
Indus®	01-71007-81	FDA UDI	Class II	Active
PedFuse	01-80048-50	FDA UDI	Class II	Active
A-Cift	14-32119-1005	FDA UDI	Class II	Active
A-Cift	01-32021-1810-HA	FDA UDI	Class II	Active

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Authorities

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FDA Recalls (33)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 13, 2019	Z-1973-2019	—	terminated	There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
Mar 5, 2015	Z-1479-2015	—	terminated	The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
Dec 19, 2014	Z-0977-2015	—	terminated	A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Nov 20, 2013	Z-0573-2014	—	terminated	Mismarked and unmarked screws
Nov 20, 2013	Z-0575-2014	—	terminated	Mismarked and unmarked screws
Nov 20, 2013	Z-0554-2014	—	terminated	Screw inserters may not mate properly with hex interface of the screws.
Nov 20, 2013	Z-0574-2014	—	terminated	Mismarked and unmarked screws
Nov 20, 2013	Z-0555-2014	—	terminated	Screw inserters may not mate properly with hex interface of the screws.
Nov 20, 2013	Z-0576-2014	—	terminated	Mismarked and unmarked screws
Nov 20, 2013	Z-0553-2014	—	terminated	Screw inserters may not mate properly with hex interface of the screws.
Oct 18, 2013	Z-0544-2014	—	terminated	During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
Sep 24, 2013	Z-0776-2014	—	terminated	Handles and heads may not be compatible.
Sep 24, 2013	Z-0778-2014	—	terminated	Handles and heads may not be compatible.
Sep 24, 2013	Z-0777-2014	—	terminated	Handles and heads may not be compatible.
Sep 11, 2013	Z-0624-2014	—	terminated	Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Aug 28, 2013	Z-0274-2014	—	terminated	Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
Jun 21, 2013	Z-1933-2013	—	terminated	Difficulty removing screws from the Invue caddies.
May 24, 2013	Z-1665-2013	—	terminated	The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
May 17, 2013	Z-1664-2013	—	terminated	The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
May 10, 2013	Z-1927-2013	—	terminated	Device design.
May 7, 2013	Z-1666-2013	—	terminated	Potential for set screw to be come deformed.
Apr 25, 2013	Z-1870-2013	—	terminated	Malfunction of slap hammer.
Apr 22, 2013	Z-1958-2013	—	terminated	Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.
Mar 14, 2013	Z-1926-2013	—	terminated	Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
Nov 9, 2012	Z-1871-2013	—	terminated	Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
Oct 5, 2012	Z-1869-2013	—	terminated	Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Aug 29, 2012	Z-1932-2013	—	terminated	During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Aug 28, 2012	Z-0412-2013	—	terminated	Inspan Compressors may break at weld causing a loss of compression
Aug 22, 2012	Z-0417-2013	—	terminated	When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
May 9, 2012	Z-1957-2013	—	terminated	The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Dec 30, 2011	Z-1737-2013	—	terminated	One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
Dec 23, 2011	Z-1565-2014	—	terminated	It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
May 10, 2008	Z-1482-2013	—	terminated	During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.