PATHWAY ELIF
Intervertebral Fusion Device With Bone Graft, Lumbar
CUSTOM SPINE, INC.
The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Pathway Elif.
Pre-market Notification Details
| Device ID | K143143 |
| 510k Number | K143143 |
| Device Name: | PATHWAY ELIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CUSTOM SPINE, INC. 9 CAMPUS DR. Parsippany, NJ 07054 |
| Contact | Mahmoud Abdelgany |
| Correspondent | Mahmoud Abdelgany CUSTOM SPINE, INC. 9 CAMPUS DR. Parsippany, NJ 07054 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-07-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840916129644 | K143143 | 000 |
| 00840916129538 | K143143 | 000 |
| 00840916113445 | K143143 | 000 |
| 00840916113438 | K143143 | 000 |
| 00840916113421 | K143143 | 000 |
| 00840916113414 | K143143 | 000 |
| 00840916113407 | K143143 | 000 |
| 00840916113391 | K143143 | 000 |
| 00840916113384 | K143143 | 000 |
| 00840916129545 | K143143 | 000 |
| 00840916129552 | K143143 | 000 |
| 00840916129637 | K143143 | 000 |
| 00840916129620 | K143143 | 000 |
| 00840916129613 | K143143 | 000 |
| 00840916129606 | K143143 | 000 |
| 00840916129590 | K143143 | 000 |
| 00840916129583 | K143143 | 000 |
| 00840916129576 | K143143 | 000 |
| 00840916129569 | K143143 | 000 |
| 00840916113377 | K143143 | 000 |
Trademark Results [PATHWAY ELIF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PATHWAY ELIF 87447552 5538312 Live/Registered |
Amendia, Inc. 2017-05-12 |
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