Kyphon Inflatable Bone Tamp

K981251 is the FDA 510(k) clearance record for KYPHON INFLATABLE BONE TAMP, a class II device, cleared for Kyphon, Inc. on 1998-07-02 under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from 1976-08-23 to 2026-08-13. As of 2026-09-10, FDA records show 3 recalls naming K981251.