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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 15 of 73

Device	Model / Reference	Registries	Class	Status
Proficient™ Posterior Cervical Spine System	11-8667	FDA UDI	Class II	Active
Leva® Anterior Expandable Spacer System	11-0745	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0043	FDA UDI	Class II	Active
Salvo® Spine System	11-6893	FDA UDI	Class II	Active
Abacus® Spacer System	11-9010	FDA UDI	Class II	Active
Salvo™ Spine System	11-6676	FDA UDI	Class II	Active
Salvo™ Spine System	11-7271	FDA UDI	Class II	Active
Salvo® Spine System	13-8413	FDA UDI	Class I	Active
Stronghold® C 3D Titanium Interbody Device System	SW18107-1015	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8586	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8385	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8479	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8937	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8693	FDA UDI	Class II	Active
Spine Wave Instruments	10-7055	FDA UDI	Class I	Active
Salvo® Spine System	11-6847	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8645	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8291	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9570	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8739	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8564	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8363	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8525	FDA UDI	Class II	Active
Velocity™ Expandable Interbody System	10-2230	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8367	FDA UDI	Class II	Active
StaXx® XD System	10-1000	FDA UDI	Class II	Active
Salvo™ Spine System	11-6660	FDA UDI	Class II	Active
Sniper® Spine System	11-4835	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9861	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-L418	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8252	FDA UDI	Class II	Active
Sniper® Spine System	11-4556	FDA UDI	Class II	Active
Sniper® Spine System	11-4435	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8551	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8865	FDA UDI	Class II	Active
Salvo™ Spine System	11-6540	FDA UDI	Class II	Active
Sniper® Spine System	11-4555	FDA UDI	Class II	Active
Salvo™ Spine System	11-6558	FDA UDI	Class II	Active
Sniper® Spine System	11-4607	FDA UDI	Class II	Active
Sniper® Spine System	11-4045	FDA UDI	Class II	Active
CapSure® Spine System	11-3445	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	10-5654	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8021	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-N414	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19169-2209	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8240	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-2034	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8353	FDA UDI	Class II	Active
Salvo® Spine System	10-8735	FDA UDI	Class I	Active
Salvo™ Spine System	11-7290	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