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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 1 of 73

Device	Model / Reference	Registries	Class	Status
Exceed® Biplanar Expandable Interbody System	K261159	FDA 510(k)	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8423	FDA UDI	Class II	Active
Salvo® Spine System	11-7546	FDA UDI	Class II	Active
Sniper® Spine System	11-4366	FDA UDI	Class II	Active
Salvo® Spine System	11-7455	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8678	FDA UDI	Class II	Active
Sniper® Spine System	11-4645	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-N420	FDA UDI	Class II	Active
Salvo® Spine System	13-8193	FDA UDI	Class I	Active
Salvo™ Spine System	11-7070	FDA UDI	Class II	Active
Salvo® Spine System	11-9583	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8317	FDA UDI	Class II	Active
Salvo® Spine System	10-8308	FDA UDI	Class I	Active
Paramount® Anterior Cervical Spine System	21-8954	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8962	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8652	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8545	FDA UDI	Class II	Active
Salvo® Spine System	11-6938	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8902	FDA UDI	Class II	Active
Salvo™ Spine System	11-6564	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8376	FDA UDI	Class II	Active
Accent® Cervical Spacer System	15-6007	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8136	FDA UDI	Class II	Active
Salvo® Spine System	10-8406	FDA UDI	Class I	Active
Salvo® Spine System	11-6936	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8701	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8171	FDA UDI	Class II	Active
CapSure® Spine System	11-3836	FDA UDI	Class II	Active
Sniper® Spine System	11-4374	FDA UDI	Class II	Active
CapSure® Spine System	11-3646	FDA UDI	Class II	Unknown
CapSure® Spine System	11-3752	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8448	FDA UDI	Class II	Active
CapSure® Spine System	11-3275	FDA UDI	Class II	Active
Salvo™ Spine System	11-6555	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8620	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9557	FDA UDI	Class II	Active
True Position® Spacer System	1208-01-3610	FDA UDI	Class II	Active
Sniper® Spine System	11-4101	FDA UDI	Class II	Active
CapSure® Spine System	11-3446	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8999	FDA UDI	Class II	Active
Salvo® Spine System	11-6550	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9895	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5348	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8463	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19169-2509	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19159-2211	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8275	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8761	FDA UDI	Class II	Active
Salvo® Spine System	13-8229	FDA UDI	Class I	Active
Sniper® Spine System	11-4615	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