Is this your brand? Sign in to claim ownership.

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 12 of 73

Device	Model / Reference	Registries	Class	Status
Proficient™ Posterior Cervical Spine System	21-8439	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8526	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8964	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0847	FDA UDI	Class II	Active
Sniper® Spine System	11-4070	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8475	FDA UDI	Class II	Active
Salvo® Spine System	13-8167	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	11-9509	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8421	FDA UDI	Class II	Active
Salvo® Spine System	11-7467	FDA UDI	Class II	Active
Salvo® Spine System	11-6806	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8426	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9487	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8782	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9827	FDA UDI	Class II	Active
Sniper® Spine System	11-4114	FDA UDI	Class II	Active
Sniper® Spine System	11-4603	FDA UDI	Class II	Active
Stronghold® C 3D Titanium Interbody Device System	SW18107-1406	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8676	FDA UDI	Class II	Active
Leva® Spacer System	10-7131.3	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8066	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8709	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8498	FDA UDI	Class II	Active
Salvo® Spine System	13-8158	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8800	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8685	FDA UDI	Class II	Active
Salvo™ Spine System	11-6687	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8695	FDA UDI	Class II	Active
Annex® Adjacent Level System	10-5012	FDA UDI	Class II	Active
Leva™ Spacer System	11-7014	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8026	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8913	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8354	FDA UDI	Class II	Active
Salvo® Spine System	11-6790	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9434	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8257	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-N416	FDA UDI	Class II	Active
Salvo® Spine System	13-8219	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-9062	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9572	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8894	FDA UDI	Class II	Active
Salvo® Spine System	11-6559	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9336	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9934	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9840	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8559	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8520	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0158	FDA UDI	Class II	Active
Sniper® Spine System	11-4104	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8755	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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