The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Camber Spine Technologies Spira - V™ Open Matrix Corpectomy Cage.
| Device ID | K173800 |
| 510k Number | K173800 |
| Device Name: | Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | Camber Spine Technologies 418 E. Lancaster Avenue Wayne, PA 19087 |
| Contact | Michael Black |
| Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B030SPV1214535330 | K173800 | 000 |
| B030SPV1214507310 | K173800 | 000 |
| B030SPV1214507290 | K173800 | 000 |
| B030SPV1214507270 | K173800 | 000 |
| B030SPV1214507250 | K173800 | 000 |
| B030SPV1214507230 | K173800 | 000 |
| B030SPV1214507210 | K173800 | 000 |
| B030SPV1214507190 | K173800 | 000 |
| B030SPV1214507170 | K173800 | 000 |
| B030SPV1214507330 | K173800 | 000 |
| B030SPV1214535150 | K173800 | 000 |
| B030SPV1214535310 | K173800 | 000 |
| B030SPV1214535290 | K173800 | 000 |
| B030SPV1214535270 | K173800 | 000 |
| B030SPV1214535250 | K173800 | 000 |
| B030SPV1214535230 | K173800 | 000 |
| B030SPV1214535210 | K173800 | 000 |
| B030SPV1214535190 | K173800 | 000 |
| B030SPV1214535170 | K173800 | 000 |
| B030SPV1214507150 | K173800 | 000 |