Spectrum Spine Inc
Jasper, GA, US
SPECTRUM SPINE INC appears in FDA device records in Jasper, GA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Spectrum Spine Inc between 2013 and 2026. The busiest year on record is 2013, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 2 |
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | ODP | Substantially Equivalent | |
| K253377 | Expandable Titanium PLIF/TLIF System | MAX | Substantially Equivalent | |
| K243074 | Spectrum Spine Lumbar Cage System | MAX | Substantially Equivalent | |
| K240838 | Spectrum Spine Cervical Cage System | ODP | Substantially Equivalent | |
| K201024 | Expandable Titanium PLIF/TLIF System | MAX | Substantially Equivalent | |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | MAX | Substantially Equivalent | |
| K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | MRW | Substantially Equivalent | |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | NQW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3036496433 | 3036496433 | SPECTRUM SPINE INC | 20 Harmony Ct, Jasper, GA 30143 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain