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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 2 of 73

Device	Model / Reference	Registries	Class	Status
Proficient™ Posterior Cervical Spine System	11-8979	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9485	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8780	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8605	FDA UDI	Class II	Active
StaXx® XD System	11-1529	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8137	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8703	FDA UDI	Class II	Active
CapSure® Spine System	11-3260	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8133	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	11-5513	FDA UDI	Class II	Active
Salvo® Spine System	11-7605	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9852	FDA UDI	Class II	Active
Sniper® Spine System	11-4030	FDA UDI	Class II	Active
Salvo® Spine System	10-8388	FDA UDI	Class I	Active
StaXx® XD System	11-1669	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8310	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8104	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5342	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8903	FDA UDI	Class II	Active
Salvo® Spine System	11-6403	FDA UDI	Class II	Active
Salvo® Spine System	10-6280	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8690	FDA UDI	Class II	Active
CapSure® Spine System	10-3229	FDA UDI	Class II	Active
Salvo® Spine System	21-0036	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8761	FDA UDI	Class II	Active
Salvo® Spine System	13-8141	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	21-8314	FDA UDI	Class II	Active
Salvo® Spine System	13-8191	FDA UDI	Class I	Active
Salvo® Spine System	11-7545	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8787	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8056	FDA UDI	Class II	Active
Sniper® Spine System	11-4203	FDA UDI	Class II	Active
Leva® Anterior Expandable Spacer System	11-0785	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8383	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0116	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8555	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9209	FDA UDI	Class II	Active
Paramount™ Anterior Cervical Spine System	11-5574	FDA UDI	Class II	Active
Sniper® Spine System	11-4293	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9475	FDA UDI	Class II	Active
Paramount® Anterior Cervical Spine System	21-8952	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0064	FDA UDI	Class II	Active
Salvo® Spine System	13-8198	FDA UDI	Class I	Active
Proficient® Posterior Cervical Spine System	21-8507	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19109-2214	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8908	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0049	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8174	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9919	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8759	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