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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 10 of 73

Device	Model / Reference	Registries	Class	Status
Proficient® Posterior Cervical Spine System	11-9841	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8020	FDA UDI	Class II	Active
CapSure® Spine System	11-3935	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8890	FDA UDI	Class II	Active
Accent® Cervical Spacer System	15-4010	FDA UDI	Class II	Active
CapSure® Spine System	11-3652	FDA UDI	Class II	Active
Sniper® Spine System	11-4750	FDA UDI	Class II	Active
Salvo® Spine System	10-8254	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	21-8335	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	10-8105	FDA UDI	Class II	Active
Salvo® Spine System	13-8415	FDA UDI	Class I	Active
Spine Wave Instruments	10-1081	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	11-8332	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9849	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19109-2207	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9724	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8427	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8774	FDA UDI	Class II	Active
Salvo® Spine System	10-8284	FDA UDI	Class I	Active
Salvo™ Spine System	11-6546	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8471	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8764	FDA UDI	Class II	Active
Leva™ Spacer System	11-7308	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	11-5521	FDA UDI	Class II	Active
Accent® Cervical Spacer System	15-4007	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8456	FDA UDI	Class II	Active
Abacus® Spacer System	11-9055	FDA UDI	Class II	Active
Leva® Anterior Expandable Spacer System	10-0310	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8571	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8915	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8577	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9566	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8007	FDA UDI	Class II	Active
Sniper® Spine System	11-4431	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-9138	FDA UDI	Class II	Active
Sniper® Spine System	11-4190	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9238	FDA UDI	Class II	Active
Abacus® Spacer System	11-9080	FDA UDI	Class II	Active
Leva® Anterior Expandable Spacer System	10-0316	FDA UDI	Class II	Active
Abacus® Spacer System	11-9030	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5366	FDA UDI	Class II	Active
Salvo® Spine System	11-6942	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8737	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8487	FDA UDI	Class II	Active
Salvo™ Spine System	10-8282	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8429	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8113	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0030.3	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8435	FDA UDI	Class II	Active
Sniper® Spine System	11-4160	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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