Flospine LLC
Boca Raton, FL, US
FLOSPINE LLC appears in FDA device records in Boca Raton, FL. FDA records list 4 510(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 4 510(k) clearances for Flospine LLC between 2014 and 2023. The busiest year on record is 2014, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223231 | Ti-Largo Cervical Interbody System | ODP | Substantially Equivalent | |
| K210182 | PANAMA™ Anterior Cervical Plate (ACP) System | KWQ | Substantially Equivalent | |
| K193255 | Largo PEEK Interbody System | MAX | Substantially Equivalent | |
| K141850 | FLOSPINE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011513267 | 3011513267 | FLOSPINE LLC | 3998 FAU Blvd, Boca Raton, FL 33431 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYQAccessories, Fixation, Spinal Intervertebral Body
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- KTZCaliper
- KDGChisel (Osteotome)
- HTPFile
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWMOsteotome
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- HTCPliers, Surgical
- HXBProbe
- HXOPusher, Socket
- HTRRasp
- HTXRongeur
- HXXScrewdriver
- PEKSpinous Process Plate
- HXGTamp
- HWXTap, Bone
- NKBThoracolumbosacral Pedicle Screw System
- HXCWrench
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