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FDA 510(k)

SPINA SYSTEM

K-Number: K033231 · 2005-09-09

ApplicantNorth American Medical Corp (Nam)
Decision Date2005-09-09
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPINA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is North American Medical Corp (Nam). It received FDA 510(k) clearance on 2005-09-09 under 510(k) number K033231. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINA SYSTEM?

SPINA SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-09. The listed applicant is North American Medical Corp (Nam). The 510(k) number is K033231.

When did SPINA SYSTEM receive FDA 510(k) clearance?

SPINA SYSTEM received FDA 510(k) clearance on 2005-09-09, under 510(k) number K033231.

Who is the listed applicant for SPINA SYSTEM?

The FDA 510(k) record lists North American Medical Corp (Nam) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINA SYSTEM?

The FDA product code for SPINA SYSTEM is ITH.

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 North American Medical Corp (Nam) 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.

K073132MODEL D DISC FORCE

Related Devices (Code: ITH)

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.

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLCK243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLCK214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLCK222912c1TracZimmer Medizinsysteme GmbHK112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800Everyway Medical Instruments Co.,LtdK103248INTEGRITY SPINAL CARE SYSTEMIntegra Life Sciences

Official Source

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

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