Surgentec LLC
Boca Raton, FL, US
SURGENTEC LLC appears in FDA device records in Boca Raton, FL. FDA records list 29 510(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 29 510(k) clearances for Surgentec LLC between 2017 and 2026. The busiest year on record is 2024, with 9. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 9 |
| 2025 | 4 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262121 | Ion-L Navigated Instruments | OLO | Substantially Equivalent | |
| K261209 | Ion-L | MRW | Substantially Equivalent | |
| K260329 | Ion-C Navigation Instruments | OLO | Substantially Equivalent | |
| K253604 | TiLink-L Navigation Instruments | OLO | Substantially Equivalent | |
| K251714 | Ion-C | MRW | Substantially Equivalent | |
| K251720 | OsteoFlo HydroFiber | MQV | Substantially Equivalent | |
| K243949 | OsteoFlo HydroFiber | MQV | Substantially Equivalent | |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | KNW | Substantially Equivalent | |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | FMF | Substantially Equivalent | |
| K243835 | TiLink-P SI Joint Fusion System | OUR | Substantially Equivalent | |
| K242797 | OsteoFlo HydroFiber | MQV | Substantially Equivalent | |
| K243265 | Ion 3D | MRW | Substantially Equivalent | |
| K242414 | TiLink-P Joint Fusion System | OUR | Substantially Equivalent | |
| K242141 | TiLink-P SI Joint Fusion System | OUR | Substantially Equivalent | |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | KNW | Substantially Equivalent | |
| K241416 | Ion 3D | MRW | Substantially Equivalent | |
| K240720 | TiLink-P SI Joint Fusion System | OUR | Substantially Equivalent | |
| K240086 | Ion 3D | MRW | Substantially Equivalent | |
| K231716 | OsteoFlo® HydroPutty™ | MQV | Substantially Equivalent | |
| K230857 | TiLink-P SI Joint Fusion System | OUR | Substantially Equivalent | |
| K231831 | TiLink-L Joint Fusion System | OUR | Substantially Equivalent | |
| K230446 | TiLink-L SI Joint Fusion System | OUR | Substantially Equivalent | |
| K211855 | Ion Facet Screw System | MRW | Substantially Equivalent | |
| K201900 | 3D GraftRasp System | FMF | Substantially Equivalent | |
| K200064 | OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft | MQV | Substantially Equivalent | |
| K200431 | 3D GraftRasp System | FMF | Substantially Equivalent | |
| K190163 | ALARA Neuro Access Kit | PDQ | Substantially Equivalent | |
| K180937 | Graftgun Universal Graft Delivery System | FMF | Substantially Equivalent | |
| K170675 | Graftgun Universal Graft Delivery System | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012495575 | 3012495575 | SURGENTEC LLC | 911 Clint Moore Rd, Boca Raton, FL 33487 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- HRXArthroscope
- MQVFiller, Bone Void, Calcium Compound
- GDFGuide, Needle, Surgical
- KNWInstrument, Biopsy
- PDQNeurosurgical Nerve Locator
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- HTRRasp
- HAERongeur, Manual
- OURSacroiliac Joint Fixation
- FMFSyringe, Piston
- MRWSystem, Facet Screw Spinal Device
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