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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 11 of 73

Device	Model / Reference	Registries	Class	Status
CapSure® Spine System	11-3178	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8493	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-9120	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	21-8969	FDA UDI	Class II	Active
CapSure® Spine System	11-3861	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8712	FDA UDI	Class II	Active
Sniper® Spine System	11-4364	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-9155	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9810	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9216	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8707	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8342	FDA UDI	Class II	Active
Leva® Spacer System	10-7133.2	FDA UDI	Class II	Active
Sniper® Spine System	11-4530	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9786	FDA UDI	Class II	Active
Abacus® Spacer System	11-9038	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9780	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8713	FDA UDI	Class II	Active
Salvo™ Spine System	11-6536	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5112	FDA UDI	Class II	Active
Salvo® Spine System	11-7937	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9507	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8933	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8693	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8513	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8411	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8478	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8733	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8724	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5810	FDA UDI	Class II	Active
Spine Wave Instruments	10-8523.1	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	11-9799	FDA UDI	Class II	Active
Sniper® Spine System	11-4830	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9883	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19109-3011	FDA UDI	Class II	Active
Salvo® Spine System	11-7456	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19109-2213	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9569	FDA UDI	Class II	Active
Salvo™ Spine System	11-7062	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8738	FDA UDI	Class II	Active
Sniper® Spine System	11-4224	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9736	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19169-3008	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9564	FDA UDI	Class II	Active
Salvo® Spine System	10-6305	FDA UDI	Class I	Active
Salvo® Spine System	13-8222	FDA UDI	Class I	Active
Paramount® Anterior Cervical Spine System	10-9026	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8102	FDA UDI	Class II	Active
Spine Wave Instruments	10-7804	FDA UDI	Class I	Active
CapSure® Spine System	11-3870	FDA UDI	Class II	Active

Related Companies

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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