ACIF
Intervertebral Fusion Device With Bone Graft, Cervical
CoLigne, AG
The following data is part of a premarket notification filed by Coligne, Ag with the FDA for Acif.
Pre-market Notification Details
| Device ID | K173148 |
| 510k Number | K173148 |
| Device Name: | ACIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | coLigne, AG Utoquai 43 Zurich, CH Ch 8008 |
| Contact | Robert Lange |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-12-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640173166665 | K173148 | 000 |
| 07640173166535 | K173148 | 000 |
| 07640173166528 | K173148 | 000 |
| 07640173166511 | K173148 | 000 |
| 07640173166504 | K173148 | 000 |
| 07640173166498 | K173148 | 000 |
| 07640173166481 | K173148 | 000 |
| 07640173166474 | K173148 | 000 |
| 07640173166467 | K173148 | 000 |
| 07640173166450 | K173148 | 000 |
| 07640173166542 | K173148 | 000 |
| 07640173166559 | K173148 | 000 |
| 07640173166566 | K173148 | 000 |
| 07640173166658 | K173148 | 000 |
| 07640173166641 | K173148 | 000 |
| 07640173166634 | K173148 | 000 |
| 07640173166627 | K173148 | 000 |
| 07640173166610 | K173148 | 000 |
| 07640173166603 | K173148 | 000 |
| 07640173166597 | K173148 | 000 |
| 07640173166580 | K173148 | 000 |
| 07640173166573 | K173148 | 000 |
| 07640173166443 | K173148 | 000 |
Trademark Results [ACIF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACIF 79067662 3781331 Live/Registered |
EMILCERAMICA S.R.L. 2009-02-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.