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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 3 of 73

Device	Model / Reference	Registries	Class	Status
Proficient® Posterior Cervical Spine System	11-9923	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8178	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9912	FDA UDI	Class II	Active
Leva® Spacer System	10-7132.3	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8533	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0083	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8470	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-1010	FDA UDI	Class II	Active
Salvo® Spine System	10-8283	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8615	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8594	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	21-8955	FDA UDI	Class II	Active
Leva® Spacer System	11-7222	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8398	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9904	FDA UDI	Class II	Active
Sniper® Spine System	11-4335	FDA UDI	Class II	Active
Salvo® Spine System	11-6805	FDA UDI	Class II	Active
Salvo® Spine System	13-8199	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8657	FDA UDI	Class II	Active
Sniper® Spine System	11-4229	FDA UDI	Class II	Active
Salvo™ Spine System	11-7072	FDA UDI	Class II	Active
Salvo™ Spine System	11-6686	FDA UDI	Class II	Active
Sniper® Spine System	11-4284	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8684	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8353	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8466	FDA UDI	Class II	Active
Sniper® Spine System	11-4185	FDA UDI	Class II	Active
Sniper® Spine System	11-4216	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0117	FDA UDI	Class II	Active
Stronghold® C 3D Titanium Interbody Device System	SW18105-1015	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8306	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8804	FDA UDI	Class II	Active
Annex® Adjacent Level System	10-5007	FDA UDI	Class II	Active
Salvo® Spine System	11-7383	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8578	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8929	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8941	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0869	FDA UDI	Class II	Active
Salvo® Spine System	10-8270	FDA UDI	Class I	Active
Salvo® Spine System	10-8238	FDA UDI	Class I	Active
Salvo® Spine System	11-6962	FDA UDI	Class II	Active
Sniper® Spine System	11-4065	FDA UDI	Class II	Active
Salvo™ Spine System	11-7275	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9505	FDA UDI	Class II	Active
CapSure® Spine System	11-3790	FDA UDI	Class II	Active
CapSure® Spine System	11-3214	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-4068	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8806	FDA UDI	Class II	Active
Sniper® Spine System	10-4227	FDA UDI	Class II	Active
Salvo® Spine System	10-5070	FDA UDI	Class I	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