Product code NQO ยท Class 3
Prosthesis, Spinous Process Spacer/Plate
0510(k)s in 12 months (0 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in NQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Neuromodulation Corporation | 0 | 3 |
| Kyphon Inc | 0 | 1 |
| St. Francis Medical Technologies Inc | 0 | 1 |
| Theragenics Corporation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2025 | Boston Scientific Neuromodulation Corporation Superion IDS Kit
Superion Indirect Decompression System 8MM, VF Implant
101-9808
00884662000529
Superion Indirect Decompression System 10MM, VF Implant
101-9810
00884662000536
Superion Indirect Deco Open, Classified |
NQO | None listed |
| Jun 15, 2023 | Boston Scientific Neuromodulation Corporation Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual Open, Classified |
NQO | None listed |
| Nov 14, 2022 | Boston Scientific Neuromodulation Corporation Superion Indirect Decompression System (IDS)
Model Numbers and Size:
101-9808 - 8mm
01-9812 - 12mm
101-9814 - 14mm Open, Classified |
NQO | None listed |
| Mar 31, 2009 | Theragenics Corporation Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518.
The Terminated |
NQO | K072296 |
| Sep 29, 2008 | Kyphon Inc X-STOP Interspinous Process Decompression (lPD) System,
(With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device);
Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM Terminated |
NQO | None listed |
| Jul 26, 2006 | St. Francis Medical Technologies Inc St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a Terminated |
NQO | None listed |
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