The following data is part of a premarket notification filed by Algea Therapies with the FDA for Affirm (tm) Vcf System.
| Device ID | K110998 |
| 510k Number | K110998 |
| Device Name: | AFFIRM (TM) VCF SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | ALGEA THERAPIES 2560 GENERAL ARMISTEAD AVENUE Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker ALGEA THERAPIES 2560 GENERAL ARMISTEAD AVENUE Audubon, PA 19403 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-10-25 |
| Summary: | summary |