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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 13 of 73

Device	Model / Reference	Registries	Class	Status
Proficient™ Posterior Cervical Spine System	11-8696	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0168	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-9136	FDA UDI	Class II	Active
Salvo® Spine System	11-6964	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8584	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8509	FDA UDI	Class II	Active
Salvo® Spine System	11-6934	FDA UDI	Class II	Active
Salvo® Spine System	11-6959	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8668	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8434	FDA UDI	Class II	Active
CapSure® Spine System	11-3746	FDA UDI	Class II	Unknown
Sniper® Spine System	11-4450	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9806	FDA UDI	Class II	Active
CapSure® Spine System	11-3837	FDA UDI	Class II	Active
CapSure® Spine System	11-3736	FDA UDI	Class II	Unknown
Defender™ Anterior Cervical Plate System	15-5224	FDA UDI	Class II	Active
Salvo® Spine System	11-7948	FDA UDI	Class II	Active
Tornado™	11-5802	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8772	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5360	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5122	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9901	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	10-5608	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-2024	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9740	FDA UDI	Class II	Active
Salvo™ Spine System	11-6530	FDA UDI	Class II	Active
Salvo® Spine System	10-8479	FDA UDI	Class I	Active
Defender™ Anterior Cervical Plate System	15-5357	FDA UDI	Class II	Active
Sniper® Spine System	10-4222	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8526	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-1020	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8039	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8783	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5454	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	10-5629	FDA UDI	Class II	Active
Salvo® Spine System	10-8266	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8713	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9424	FDA UDI	Class II	Active
Leva® Anterior Expandable Spacer System	11-0705	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8440	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8427	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8452	FDA UDI	Class II	Active
Sniper® Spine System	11-4770	FDA UDI	Class II	Active
Salvo® Spine System	11-6673	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8542	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8100	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0184	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9227	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8461	FDA UDI	Class II	Active
Abacus® Spacer System	11-9105	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