EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
Thoracolumbosacral Pedicle Screw System
Medos-International, SARL
The following data is part of a premarket notification filed by Medos-international, Sarl with the FDA for Expedium® Spine System, Expedium Verse® Spine System: Altalyne™ Ultra Rods.
Pre-market Notification Details
| Device ID | K222473 |
| 510k Number | K222473 |
| Device Name: | EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medos-International, SARL Chemin Blanc 38 Le Locle, CH 2400 |
| Contact | Denielle Smith |
| Correspondent | Denielle Smith DePuy Spine 325 Paramount Dr. Raynham, MA 02767 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-16 |
| Decision Date | 2022-10-13 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034566542 | K222473 | 000 |
| 10705034566405 | K222473 | 000 |
| 10705034566412 | K222473 | 000 |
| 10705034566429 | K222473 | 000 |
| 10705034566436 | K222473 | 000 |
| 10705034566443 | K222473 | 000 |
| 10705034566450 | K222473 | 000 |
| 10705034566467 | K222473 | 000 |
| 10705034566474 | K222473 | 000 |
| 10705034566481 | K222473 | 000 |
| 10705034566498 | K222473 | 000 |
| 10705034566504 | K222473 | 000 |
| 10705034566511 | K222473 | 000 |
| 10705034566528 | K222473 | 000 |
| 10705034566535 | K222473 | 000 |
| 10705034566399 | K222473 | 000 |
Trademark Results [EXPEDIUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXPEDIUM 78421902 3072007 Live/Registered |
DePuy Synthes, Inc. 2004-05-19 |
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