The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Kyphx Inflatable Bone Tamp, Size 20/3,model K01a, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02a.
| Device ID | K010246 |
| 510k Number | K010246 |
| Device Name: | KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A |
| Classification | Arthroscope |
| Applicant | KYPHON, INC. 1350 BORDEAUX DR. Sunnyvale, CA 94089 |
| Contact | Karen Talmadge |
| Correspondent | Karen Talmadge 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 | 2001-01-26 |
| Decision Date | 2001-02-14 |