FDA 510(k)

KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A

K-Number: K010246 · 2001-02-14

Decision Date2001-02-14

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A is the device name listed in this FDA 510(k) record. The listed applicant is Kyphon, Inc.. It received FDA 510(k) clearance on 2001-02-14 under 510(k) number K010246. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A?

KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Kyphon, Inc.. The 510(k) number is K010246.

When did KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A receive FDA 510(k) clearance?

KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A received FDA 510(k) clearance on 2001-02-14, under 510(k) number K010246.

Who is the listed applicant for KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A?

The FDA 510(k) record lists Kyphon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A?

The FDA product code for KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A is HRX.

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Other records listing Kyphon, Inc. as applicant

K073516DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR K063071DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B K061210FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B K041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A K041584KYPHX HV-R BONE CEMENT, MODEL C01A K033801KYPHX HV-R, MODEL C01A

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.