Manufacturer registered with FDA

VB Spine, LLC

New York, NY, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10093189Specification developer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
661 registrations outside the US
Establishments
1United States

Registered in 6 markets

Where regulators' registries name VB Spine, LLC as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedBrazil: 24 registrationsIsrael: 13 registrationsTaiwan: 12 registrationsColombia: 6 registrationsPeru: 6 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerVB Spine, LLC1 device types—Below
BrazilANVISAManufacturerSTRYKER SPINE242005–2026Pure Global AI
IsraelAMARManufacturerStryker Spine, Inc.Stryker Spine · Stryker Spine, INC.13—Pure Global AI
TaiwanTFDAManufacturerStryker Spine122000–2021Pure Global AI
ColombiaINVIMAManufacturerSTRYKER SPINESTRYKER SPINE INC6—Pure Global AI
PeruDIGEMIDManufacturerSTRYKER SPINE62021–2022Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What VB Spine, LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Synthetic Bone Grafting MaterialLYC · Class 2Bone grafts & membranesMaker
VITOMATRIX BONE GRAFTING MATERIAL
2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

VB Spine, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Orthovita, Inc. (1).

Decided510(k)DeviceApplicantDevice type
27 Sep 2010K091618VITOMATRIXOrthovita, Inc.LYC Synthetic Bone Grafting Material

Registered establishments

EstablishmentLocationWhat it does
STRYKER SPINEFDA reg. 3004024955ALLENDALE, NJ, United StatesComplaint file establishment, Specification developer

Other names on FDA records

Stryker Spine

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10093189). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.