Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation 882.5880
0510(k)s in 12 months (139 all time)
1recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in GZB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | Boston Scientific Neuromodulation Corporation Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System Open, Classified |
GZB | K233801 |
| Sep 29, 2014 | St. Jude Medical, Inc. Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead).
Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. Terminated |
GZB | K123299 |
| Sep 29, 2014 | St. Jude Medical, Inc. Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead).
Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. Terminated |
GZB | K123299 |
| Apr 21, 2010 | Advanced Neuromodulation Systems, Inc Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company.
Product is intended to be used as an accessory to the leads component of ANS SCS systems, functio Terminated |
GZB | K092371 |
| Sep 18, 2008 | Medtronic Neuromodulation Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Terminated |
GZB | K971756 |
| May 25, 2006 | Medtronic Inc, Neurological & Spinal Division Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy. Terminated |
GZB | None listed |
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