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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 6 of 73

Device	Model / Reference	Registries	Class	Status
Proficient™ Posterior Cervical Spine System	11-8348	FDA UDI	Class II	Active
Salvo® Spine System	11-7550	FDA UDI	Class II	Active
Salvo™ Spine System	11-7076	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0230	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8983	FDA UDI	Class II	Active
Sniper® Spine System	11-4646	FDA UDI	Class II	Active
CapSure® Spine System	11-3295	FDA UDI	Class II	Active
Abacus® Spacer System	11-9072	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8456	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8183	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0624	FDA UDI	Class II	Active
Salvo® Spine System	10-8297	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-9139	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9326	FDA UDI	Class II	Active
CapSure® Spine System	11-3435	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8130	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8316	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8782	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9916	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9217	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-4072	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	10-8122	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9892	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8668	FDA UDI	Class II	Active
Salvo® Spine System	11-7459	FDA UDI	Class II	Active
Salvo™ Spine System	11-7288	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9440	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8965	FDA UDI	Class II	Active
Salvo® Spine System	11-9582	FDA UDI	Class II	Active
Salvo® Spine System	10-5043	FDA UDI	Class I	Active
GraftMag® Graft Delivery System	13-3542	FDA UDI	Class I	Active
Leva® Anterior Interbody System	11-0047	FDA UDI	Class II	Active
Salvo® Spine System	11-7498	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9910	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9794	FDA UDI	Class II	Active
Salvo® Spine System	13-8201	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8651	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8303	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8523	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9832	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8906	FDA UDI	Class II	Active
Spine Wave Instruments	10-7808	FDA UDI	Class I	Active
Paramount® Anterior Cervical Spine System	10-9036	FDA UDI	Class II	Active
Sniper® Spine System	11-4211	FDA UDI	Class II	Active
Salvo® Spine System	11-7454	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9826	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8093	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9532	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8379	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8528	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