The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Kyphon Inflatable Bone Tamp.
| Device ID | K981251 |
| 510k Number | K981251 |
| Device Name: | KYPHON INFLATABLE BONE TAMP |
| Classification | Arthroscope |
| Applicant | KYPHON, INC. 3110 CORONADO DR. Santa Clara, CA 95054 |
| Contact | Karen Talmadge |
| Correspondent | Karen Talmadge KYPHON, INC. 3110 CORONADO DR. Santa Clara, CA 95054 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-06 |
| Decision Date | 1998-07-02 |
| Summary: | summary |