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)

TRANSCORP SPINAL ACCESS SYSTEM

K-Number: K113352 · 2012-04-16

ApplicantTranscorp, Inc.
Decision Date2012-04-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANSCORP SPINAL ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Transcorp, Inc.. It received FDA 510(k) clearance on 2012-04-16 under 510(k) number K113352. 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 TRANSCORP SPINAL ACCESS SYSTEM?

TRANSCORP SPINAL ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-16. The listed applicant is Transcorp, Inc.. The 510(k) number is K113352.

When did TRANSCORP SPINAL ACCESS SYSTEM receive FDA 510(k) clearance?

TRANSCORP SPINAL ACCESS SYSTEM received FDA 510(k) clearance on 2012-04-16, under 510(k) number K113352.

Who is the listed applicant for TRANSCORP SPINAL ACCESS SYSTEM?

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

What is the FDA product code for TRANSCORP SPINAL ACCESS SYSTEM?

The FDA product code for TRANSCORP SPINAL ACCESS 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 Transcorp, 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.

K121178TRANSCORP ACIF SYSTEMK092794TRANSCORP ACIF SYSTEMK092695TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM

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.

↑