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)

B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)

K-Number: K032358 · 2003-12-17

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2003-12-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2003-12-17 under 510(k) number K032358. 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 B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)?

B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) is a medical device that received FDA 510(k) clearance on 2003-12-17. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K032358.

When did B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) receive FDA 510(k) clearance?

B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) received FDA 510(k) clearance on 2003-12-17, under 510(k) number K032358.

Who is the listed applicant for B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)?

The FDA 510(k) record lists Disc-O-Tech Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)?

The FDA product code for B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) 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 Disc-O-Tech Medical Technologies, Ltd. 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.

K071375MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)K071679METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMSK063067CONFIDENCE FENESTRATED INTRODUCER NEEDLEK062424CONFIDENCE EX HIGH VISCOSITY BONE CEMENTK060300CONFIDENCE HIGH VISCOSITY BONE CEMENTK040612SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

View all 16 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.

↑