Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A

K-Number: K041454 · 2004-07-09

ApplicantKyphon, Inc.
Decision Date2004-07-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A is the device name listed in this FDA 510(k) record. The listed applicant is Kyphon, Inc.. It received FDA 510(k) clearance on 2004-07-09 under 510(k) number K041454. 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 XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A?

KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A is a medical device that received FDA 510(k) clearance on 2004-07-09. The listed applicant is Kyphon, Inc.. The 510(k) number is K041454.

When did KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A receive FDA 510(k) clearance?

KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A received FDA 510(k) clearance on 2004-07-09, under 510(k) number K041454.

Who is the listed applicant for KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A?

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 XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A?

The FDA product code for KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A is HRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kyphon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073516DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULARK063071DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01BK061210FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01BK041584KYPHX HV-R BONE CEMENT, MODEL C01AK033801KYPHX HV-R, MODEL C01AK032212KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

View all 9 devices →

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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.

↑