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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 4 of 73

Device	Model / Reference	Registries	Class	Status
Proficient™ Posterior Cervical Spine System	11-8023	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9223	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8535	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0145	FDA UDI	Class II	Active
CapSure® Spine System	11-3631	FDA UDI	Class II	Unknown
Proficient™ Posterior Cervical Spine System	11-8337	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9813	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5812	FDA UDI	Class II	Active
CapSure® Spine System	11-3301	FDA UDI	Class II	Active
Annex® Adjacent Level System	11-5050	FDA UDI	Class II	Active
Leva™ Spacer System	11-7309	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8771	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8402	FDA UDI	Class II	Active
Abacus® Spacer System	11-9043	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8374	FDA UDI	Class II	Active
Salvo® Spine System	11-7503	FDA UDI	Class II	Active
Exceed™ Biplanar Expandable Interbody System	11-5415	FDA UDI	Class II	Active
Sniper® Spine System	11-4187	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8758	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-N412	FDA UDI	Class II	Active
Salvo® Spine System	13-8230	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	11-8089	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8263	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9554	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8384	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8695	FDA UDI	Class II	Active
Spine Wave Instruments	10-7801	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	11-8783	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	10-5603	FDA UDI	Class II	Active
Abacus® Spacer System	11-9041	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8664	FDA UDI	Class II	Active
Ni-Lock® Anterior Cervical Plate System	15-3054	FDA UDI	Class II	Active
Abacus® Spacer System	11-9091	FDA UDI	Class II	Active
GraftMag® Graft Delivery System	13-3543	FDA UDI	Class I	Active
Accent® Cervical Spacer System	15-4006	FDA UDI	Class II	Active
Spine Wave Instruments	10-7051	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8790	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19159-2509	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	10-9035	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9825	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8290	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8671	FDA UDI	Class II	Active
Sniper® Spine System	11-4331	FDA UDI	Class II	Active
Sniper® Spine System	11-4606	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8767	FDA UDI	Class II	Active
Annex® Adjacent Level System	11-5052	FDA UDI	Class II	Active
Salvo™ Spine System	11-7273	FDA UDI	Class II	Active
Stronghold® C 3D Titanium Interbody Device System	SW18107-0515	FDA UDI	Class II	Active
Spine Wave Instruments	10-1677	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8720	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