Endius, Inc.
Plainville, MA, US
Endius, Inc. appears in FDA device records in Plainville, MA. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Endius, Inc. between 1997 and 2008. The busiest year on record is 2001, with 7. The most recent is 2008, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 4 |
| 2000 | 4 |
| 2001 | 7 |
| 2002 | 6 |
| 2004 | 1 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080258 | MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K073510 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K073267 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K072840 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K070282 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K070367 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K061345 | MODIFICATION TO ENDIUS ATAVI SYSTEM | HRX | Substantially Equivalent | |
| K060990 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K060683 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K053267 | ENDIUS ATAVI SYSTEM | HRX | Substantially Equivalent | |
| K041808 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K022199 | ENDIUS ATAVI SYSTEM | HRX | Substantially Equivalent | |
| K022578 | ENDIUS FLEXTIP BLADE | HRX | Substantially Equivalent | |
| K021881 | ENDIUS TITLE SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K021748 | ENDIUS ATAVI SYSTEM | HRX | Substantially Equivalent | |
| K014090 | ENDIUS SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K014107 | ENDIUS CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K013403 | TRI-FIX SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K012488 | MODIFICATION TO:ENDIUS BIPOLAR SHEATH | GEI | Substantially Equivalent | |
| K011830 | TRI-FIX SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K010922 | TRI-FIX SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K010903 | TRI-FIX SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K003897 | ENDIUS BIPOLAR SHEATH | GEI | Substantially Equivalent | |
| K010535 | TRIFIX SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K002437 | ENDIUS ENDOSCOPIC ACCESS SYSTEM | HRX | Substantially Equivalent | |
| K001627 | TRIFIX SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K000766 | TRI-FIX SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K994425 | MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM | HRX | Substantially Equivalent | |
| K992535 | ENDIUS SUCTION/IRRIGATION INSTRUMENT | OCX | Substantially Equivalent | |
| K991794 | ENDOSCOPIC SPINAL ACCESS SYSTEM | HRX | Substantially Equivalent | |
| K983144 | FLEXPOSURE RETRACTOR | HRX | Substantially Equivalent | |
| K982819 | ENDIUS SPINE ENDOSCOPE | GWG | Substantially Equivalent | |
| K972450 | FLEXTIP GRASPER | EOB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GWGEndoscope, Neurological
- OCXEndoscopic Irrigation/Suction System
- EOBNasopharyngoscope (Flexible Or Rigid)
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain