510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010246Substantially Equivalent

Kyphx Inflatable Bone Tamp, Size 20/3,Model K01a, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02a

Medtronic, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010246 is the FDA 510(k) clearance record for KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A, a class II device, cleared for Kyphon, Inc. on 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 to . As of , FDA records show 3 recalls naming K010246.

Clearance record

Decision date
Received
(19 days to decision)
Product code
HRX Arthroscope
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Applicant
Kyphon, Inc. 1350 Bordeaux Dr., Sunnyvale CA
510(k) summary
Summary
Third party review
No

Clearances, product code HRX

Trailing 12 months
9 clearances under product code HRX in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code HRX, trailing twelve months
MonthClearances
November 20252
December 20252
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20262
September 20260
October 20260