Product code MJO ยท Class 3
Prosthesis, Intervertebral Disc
0510(k)s in 12 months (0 all time)
3recalls in 12 months (15 all time)
0recalls that name a 510(k)
Top companies in MJO
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek USA Inc | 0 | 7 |
| Centinel Spine, Inc. | 0 | 6 |
| Medicrea International | 0 | 1 |
| NuVasive Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Centinel Spine, Inc. Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6.
Total cervical disc replacement. Open, Classified |
MJO | None listed |
| May 1, 2026 | Centinel Spine, Inc. Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5
Total cervical disc replacement. Open, Classified |
MJO | None listed |
| Feb 17, 2026 | Centinel Spine, Inc. Brand Name: Prodisc
Product Name: Prodisc C SK
Model/Catalog Number: PDSL6
Software Version: N/A
Product Description: Total cervical disc replacement
Component: No Open, Classified |
MJO | None listed |
| Sep 24, 2024 | Centinel Spine, Inc. prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 Open, Classified |
MJO | None listed |
| Sep 24, 2024 | Centinel Spine, Inc. prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5 Open, Classified |
MJO | None listed |
| Aug 24, 2023 | Medicrea International GRANVIA-C, REF numbers:
a) A13111427,
b) A13112567,
c) A13113456,
d) A13131516,
e) A13131789,
f) A13132012,
g) B13111014,
h) B13111015,
i) B13111016,
j) B13111017,
k) B13111025,
l) B13111 Open, Classified |
MJO | None listed |
| Jun 20, 2022 | NuVasive Inc Description/Part:
Simplify Disc Size 1, Ht 5/SM-5;
Simplify Disc Size 1, Ht 6/SM-6;
Simplify Disc Size 2, Ht 4/MD-4;
Simplify Disc Size 2, Ht 5/MD-5;
Simplify Disc Size 2, Ht 5, 5/MD-5L;
Simplify Dis Open, Classified |
MJO | None listed |
| Mar 5, 2021 | Centinel Spine, Inc. Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptom Terminated |
MJO | None listed |
| Mar 13, 2018 | Medtronic Sofamor Danek USA Inc Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES:
a) REF 6975205, 5mm
b) REF 6975206, 6mm
c) REF 6975207, 7mm
Product Usage:
The PRESTIGE LP reusable instrum Terminated |
MJO | None listed |
| Dec 19, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972287, SIZE 7 X 18, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA Terminated |
MJO | None listed |
| Dec 19, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog: 6972267, SIZE 7 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA Terminated |
MJO | None listed |
| Dec 19, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA Terminated |
MJO | None listed |
| Dec 19, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, SIZE 6 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA Terminated |
MJO | None listed |
| Dec 19, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA Terminated |
MJO | None listed |
| Dec 19, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA Terminated |
MJO | None listed |
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