The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Providence Cervical Cage.
| Device ID | K122801 |
| 510k Number | K122801 |
| Device Name: | PROVIDENCE CERVICAL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | PROVIDENCE MEDICAL TECHNOLOGY, INC. 3650 MT Diablo Blvd Ste 104 Lafayette, CA 94549 |
| Contact | Edward Liou |
| Correspondent | Edward Liou PROVIDENCE MEDICAL TECHNOLOGY, INC. 3650 MT Diablo Blvd Ste 104 Lafayette, CA 94549 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-13 |
| Decision Date | 2013-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852776006321 | K122801 | 000 |
| 00852776006010 | K122801 | 000 |
| 00852776006003 | K122801 | 000 |
| 10852776006017 | K122801 | 000 |
| 10852776006000 | K122801 | 000 |
| 20852776006000 | K122801 | 000 |
| 20852776006069 | K122801 | 000 |
| 00852776006423 | K122801 | 000 |