SPINEFRONTIER, INC. DBA LESspine Innovations — FDA Facility Profile
SPINEFRONTIER, INC. DBA LESspine Innovations is an FDA-registered facility (FEI 3005977257) located in Burlington, MA, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.
Reviewing SPINEFRONTIER, INC. DBA LESspine Innovations as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check SPINEFRONTIER, INC. DBA LESspine Innovations yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Apr 2, 2026: No Action Indicated (NAI)
- Inspections on record
- 6 (1 OAI, 1 VAI, 4 NAI)
- Last OAI inspection
- Jul 11, 2012
- Warning letters
- 1 listed by FDA for this FEI, latest Aug 8, 2012
- Recalls as the recalling firm
- 26, latest Jun 13, 2019
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 2, 2026 | No Action Indicated (NAI) | Corrective action records not maintained (ISO 13485:2016 Clause 8.5.2) |
| Jan 29, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 29, 2017 | No Action Indicated (NAI) | No citations listed |
| Feb 10, 2016 | No Action Indicated (NAI) | No citations listed |
| Aug 5, 2013 | No Action Indicated (NAI) | No citations listed |
| Jul 11, 2012 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Design verification - Lack of or inadequate procedures (21 CFR 820.30(f)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 5 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 13, 2019 | Class II | Z-1973-2019 | A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers… There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. |
| Mar 5, 2015 | Class II | Z-1479-2015 | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part… The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does… |
| Dec 19, 2014 | Class II | Z-0977-2015 | lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument. |
| Nov 20, 2013 | Class II | Z-0553-2014 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110
The… and 2 more products Screw inserters may not mate properly with hex interface of the screws. |
| Nov 20, 2013 | Class II | Z-0573-2014 | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered.
Used to secure the Invue… and 3 more products Mismarked and unmarked screws |
| Oct 18, 2013 | Class II | Z-0544-2014 | PedFuse Reset Screw; Model: 01-80115-55
The PedFuse Reset pedicle screw implants… During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant… |
| Sep 24, 2013 | Class II | Z-0776-2014 | Arena-L Trial Handle; Part: 11-81002
The trial heads are smooth plates that mimic the… and 2 more products Handles and heads may not be compatible. |
| Sep 11, 2013 | Class II | Z-0624-2014 | PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. |
| Aug 28, 2013 | Class II | Z-0274-2014 | S-LIFT Extension Shims
Extension shims are manufactured from grade 5 titanium and are… Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension… |
| Jun 21, 2013 | Class II | Z-1933-2013 | Indus Invue Screw Caddy, Model: SI70097
The caddy holds, in an organized fashion within… Difficulty removing screws from the Invue caddies. |
Facility details
- Company
- SpineFrontier, Inc.
- Location
- Burlington, MA (US)
- Source
- device