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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 14 of 73

Device	Model / Reference	Registries	Class	Status
StaXx® XD System	11-1550	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19109-2511	FDA UDI	Class II	Active
Salvo® Spine System	11-7613	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8331	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5118	FDA UDI	Class II	Active
Sniper® Spine System	11-4730	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9722	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0155	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9812	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9231	FDA UDI	Class II	Active
Salvo® Spine System	11-7416	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8482	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9244	FDA UDI	Class II	Active
CapSure® Spine System	11-3832	FDA UDI	Class II	Active
Leva® Spacer System	11-7023	FDA UDI	Class II	Active
Salvo® Spine System	11-7453	FDA UDI	Class II	Active
Salvo® Spine System	11-6792	FDA UDI	Class II	Active
Salvo® Spine System	11-6614	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8403	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8017	FDA UDI	Class II	Active
Salvo® Spine System	21-0008	FDA UDI	Class II	Active
Salvo® Spine System	10-5049	FDA UDI	Class I	Active
Stronghold® C 3D Titanium Interbody Device System	SW18107-1407	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0848	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19109-2509	FDA UDI	Class II	Active
Salvo® Spine System	11-7611	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	10-8566	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	10-9019	FDA UDI	Class II	Active
Salvo® Spine System	13-8202	FDA UDI	Class I	Active
Leva® Anterior Interbody System	11-0007	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0215	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9567	FDA UDI	Class II	Active
Salvo® Spine System	11-8645	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8687	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8424	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-P410	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8281	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9915	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	10-9029	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8714	FDA UDI	Class II	Active
Salvo® Spine System	13-8423	FDA UDI	Class I	Active
Tornado™	11-5801	FDA UDI	Class II	Active
Salvo® Spine System	21-0033	FDA UDI	Class II	Active
Salvo® Spine System	11-6925	FDA UDI	Class II	Active
Spine Wave Instruments	10-7807	FDA UDI	Class I	Active
Sniper® Spine System	10-4224	FDA UDI	Class II	Active
Spine Wave Instruments	10-1101	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	21-8300	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8604	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-8555	FDA UDI	Class II	Active

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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