The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Kyphx Directional Inflatable Bone Tamp, Models K16a And K17a.
| Device ID | K032212 |
| 510k Number | K032212 |
| Device Name: | KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A |
| Classification | Arthroscope |
| Applicant | KYPHON, INC. 1350 BORDEAUX DR. Sunnyvale, CA 94089 |
| Contact | Tim Reeves |
| Correspondent | Tim Reeves KYPHON, INC. 1350 BORDEAUX DR. Sunnyvale, CA 94089 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-09-15 |
| Summary: | summary |