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Spine Wave, Inc.

Last updated September 17, 2026

Information

Country: US
Address: THREE ENTERPRISE DR., SHELTON, CT, 06484
Website: spinewave.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 203-944-9494
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004638600
DUNS Number: 067789763

Catalogue (3604)

Page 9 of 73

Device	Model / Reference	Registries	Class	Status
Proficient® Posterior Cervical Spine System	21-8500	FDA UDI	Class II	Active
Sniper® Spine System	11-4055	FDA UDI	Class II	Active
Salvo™ Spine System	11-6661	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19169-2514	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	11-5512	FDA UDI	Class II	Active
Salvo® Spine System	11-7403	FDA UDI	Class II	Active
Salvo® Spine System	11-6889	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8773	FDA UDI	Class II	Active
Leva™ Spacer System	11-7114	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0868	FDA UDI	Class II	Active
Sniper® Spine System	11-4195	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8009	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-3044	FDA UDI	Class II	Active
Salvo® Spine System	13-8238	FDA UDI	Class I	Active
Paramount® Anterior Cervical Spine System	10-9040	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8692	FDA UDI	Class II	Active
Sniper® Spine System	11-4338	FDA UDI	Class II	Active
Stronghold® T 3D Titanium Interbody Device System	SW19106-3012	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8546	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8406	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9834	FDA UDI	Class II	Active
Salvo™ Spine System	11-7063	FDA UDI	Class II	Active
CapSure® Spine System	11-3751	FDA UDI	Class II	Unknown
Proficient™ Posterior Cervical Spine System	11-8887	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9556	FDA UDI	Class II	Active
Sniper® Spine System	11-4206	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8014	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5820	FDA UDI	Class II	Active
Abacus® Spacer System	11-9022	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8444	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9239	FDA UDI	Class II	Active
Accent® Cervical Spacer System	15-6610	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0086	FDA UDI	Class II	Active
Sniper® Spine System	11-4631	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5236	FDA UDI	Class II	Active
Salvo® Spine System	10-8405	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	11-9879	FDA UDI	Class II	Active
CapSure® Spine System	11-3456	FDA UDI	Class II	Active
Salvo® Spine System	11-9575	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	10-9044	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	10-8111	FDA UDI	Class II	Active
CapSure® Spine System	11-3185	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8379	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9830	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9730	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8746	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8098	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9918	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0614	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8469	FDA UDI	Class II	Active

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Authorised Representatives

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Authorities

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FDA Recalls (2)

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
May 4, 2015	Z-1960-2015	—	terminated	Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
May 14, 2013	Z-2187-2013	—	terminated	A component Superior endplate manufactured from a different polymer than specified