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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 8 of 73

Device	Model / Reference	Registries	Class	Status
Proficient™ Posterior Cervical Spine System	11-8777	FDA UDI	Class II	Active
Sniper® Spine System	11-4430	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-9147	FDA UDI	Class II	Active
Salvo® Robotic Navigation Instruments	10-8653	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8888	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9480	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8792	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8629	FDA UDI	Class II	Active
Sniper® Spine System	11-4616	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0030.1	FDA UDI	Class II	Active
Salvo® Spine System	10-5071	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	11-8274	FDA UDI	Class II	Active
Salvo™ Spine System	11-7068	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8368	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-8543	FDA UDI	Class II	Active
Salvo® Spine System	13-8414	FDA UDI	Class I	Active
Spine Wave Instruments	10-1293	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8704	FDA UDI	Class II	Active
Annex® Adjacent Level System	11-5045	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8357	FDA UDI	Class II	Active
Sniper® Spine System	11-4636	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8134	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5234	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5822	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8378	FDA UDI	Class II	Active
Salvo® Spine System	11-7397	FDA UDI	Class II	Active
Salvo® Spine System	11-6950	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8659	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8027	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9446	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8501	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9790	FDA UDI	Class II	Active
Sniper® Spine System	11-4746	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	10-5610	FDA UDI	Class II	Active
CapSure® Spine System	11-3285	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19159-2508	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8728	FDA UDI	Class II	Active
Sniper® Spine System	11-4135	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8989	FDA UDI	Class II	Active
Sniper® Spine System	11-4604	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9819	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8717	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8973	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8015	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0189	FDA UDI	Class II	Active
Spine Wave Instruments	10-1104	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8758	FDA UDI	Class II	Active
Salvo® Spine System	11-7619	FDA UDI	Class II	Active
Accent® Cervical Spacer System	15-4009	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9420	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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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