FEI 3007922509
Nexxt Spine Llc
14425 Bergen Blvd Suite B, Noblesville, IN, US
MDR events10All time
Recalls0All time
Registered products20
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
20 product codes
Recent MDR events
10 on file
- TRELLOSS 0-PROFILEDec 18, 2023InjuryMW5149362
- 66MM 3 LEVEL PLATE, 18MM VST SCREW, 16MM VST SCREW, 18MM VSD SCREWJul 15, 2020InjuryMW5095543
- NEXXT SPINE STRUXXUREAug 29, 2019MalfunctionMW5089476
- MATRIXX SYSTEMApr 11, 2019Injury3007922509-2019-00002
- MATRIXX SYSTEMApr 11, 2019Injury3007922509-2019-00003
- NEXXT MATRIXX INTERBODY SYSTEMMar 18, 2019Malfunction3007922509-2019-00001
- MATRIXX SYSTEMOct 24, 2018Injury3007922509-2018-00002
- INERTIA PEDICLE SCREW SYSTEMOct 24, 2018Injury3007922509-2018-00004
- HONOUR SPACER SYSTEMOct 24, 2018Injury3007922509-2018-00005
- NEXXT MATRIXX INTERBODY SYSTEMOct 19, 2018Malfunction3007922509-2018-00001
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3007922509.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Aug 11, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Aug 11, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Aug 11, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(c)Aug 11, 2025
Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Aug 11, 2025
Lack of or inadequate process validation
- 21 CFR 820.75(b)Aug 11, 2025
Lack/Inad procedure-Monitoring/Control of Validated Proces
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.