510(k) K223765 ยท OLO Orthopedic Stereotaxic Instrument
ATEC Lateral Navigation Instruments
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 23, 2023 |
| Received | Dec 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2026 | Alphatec Spine, Inc. ATEC Lateral Navigation Disc Prep Instruments
LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N
UDI-DI code: 00190376476179; GMDN 12844
The ATEC Navigation Disc Prep Instruments are intended for use in sur Open, Classified |
OLO | None listed |
| Feb 11, 2026 | Alphatec Spine, Inc. ATEC Lateral Navigation Disc Prep Instruments
LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N
UDI-DI code: 00190376541471; GMDN 12844
The ATEC Navigation Disc Prep Instruments are intended for use in sur Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.