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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 7 of 73

Device	Model / Reference	Registries	Class	Status
Spine Wave Instruments	10-1100	FDA UDI	Class I	Active
Ni-Lock® Anterior Cervical Plate System	15-3058	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9875	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8135	FDA UDI	Class II	Active
Salvo® Spine System	11-7388	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8111	FDA UDI	Class II	Active
CapSure® Spine System	11-3651	FDA UDI	Class II	Unknown
Proficient® Posterior Cervical Spine System	11-9233	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8078	FDA UDI	Class II	Active
Salvo® Spine System	13-8237	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8747	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19169-2214	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8661	FDA UDI	Class II	Active
Sniper® Spine System	11-4183	FDA UDI	Class II	Active
Salvo® Spine System	10-8749	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	11-8352	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8251	FDA UDI	Class II	Active
Stronghold® C 3D Titanium Interbody Device System	SW18125-1405	FDA UDI	Class II	Active
Leva™ Spacer System	11-7110	FDA UDI	Class II	Active
Salvo® Spine System	11-6692	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8628	FDA UDI	Class II	Active
Sniper® Spine System	11-4193	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0006	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-9149	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9909	FDA UDI	Class II	Active
Abacus® Spacer System	11-9031	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9436	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8633	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8508	FDA UDI	Class II	Active
Sniper® Spine System	11-4198	FDA UDI	Class II	Active
Leva® Anterior Expandable Spacer System	11-0765	FDA UDI	Class II	Active
True Position® Spacer System	1208-01-2712	FDA UDI	Class II	Active
Salvo® Spine System	11-6946	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-1024	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9809	FDA UDI	Class II	Active
Abacus® Spacer System	11-9057	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8730	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0803	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	11-5576	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9201	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-R410	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8431	FDA UDI	Class II	Active
Salvo® Spine System	13-8228	FDA UDI	Class I	Active
CapSure® Spine System	11-3051	FDA UDI	Class II	Active
Accent® Cervical Spacer System	15-4008	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	21-9013	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8976	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8722	FDA UDI	Class II	Active
Sniper® Spine System	11-4630	FDA UDI	Class II	Active
CapSure® Spine System	11-3912	FDA UDI	Class II	Active

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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