Data / Medical devices / United States / Neo Spine Usa Inc.
Neo Spine Usa Inc.: FDA-registered device maker in Hackensack, NJ, United States, 8 510(k) clearances
Neo Spine Usa Inc. is registered with the FDA (registration 3014003062) in Hackensack, NJ, United States. It lists 14 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014003062
- Address
- 411 Hackensack Avenue #, Hackensack, NJ, United States, 07601
- Owner or operator
- Neo Spine USA Inc. (10056088)
- Roles
- Complaint file establishment
- First device listed
- November 5, 2017
- Registered through
- 2026
- Brand names listed
- BonOs Inject, Cage Bent Curette Kit, Cage Instrument Kit, Cage Pusher Kit, Cage holder, Cage puller, Cage straight curette kit, Cement pusher and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | K243693 | NEO Pedicle Screw System | NKB | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| August 26, 2022 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | PML | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| October 28, 2021 | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | PML | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| May 18, 2021 | K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | LOD | Substantially Equivalent | Osartis GmbH | accessdata.fda.gov |
| December 13, 2019 | K191796 | Neo Cage System | MAX | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| January 29, 2019 | K181048 | Neo Cage System TM | MAX | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| September 12, 2017 | K171582 | NEO Pedicle Screw System | NKB | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
Compare with other makers
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- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Dispenser, Cement
Updated December 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.