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FDA 510(k)

SPINEMED

K-Number: K030060 · 2003-02-05

ApplicantCert Health Sciences, LLC
Decision Date2003-02-05
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPINEMED is the device name listed in this FDA 510(k) record. The listed applicant is Cert Health Sciences, LLC. It received FDA 510(k) clearance on 2003-02-05 under 510(k) number K030060. 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 SPINEMED?

SPINEMED is a medical device that received FDA 510(k) clearance on 2003-02-05. The listed applicant is Cert Health Sciences, LLC. The 510(k) number is K030060.

When did SPINEMED receive FDA 510(k) clearance?

SPINEMED received FDA 510(k) clearance on 2003-02-05, under 510(k) number K030060.

Who is the listed applicant for SPINEMED?

The FDA 510(k) record lists Cert Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINEMED?

The FDA product code for SPINEMED 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.

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Other records listing Cert Health Sciences, LLC 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.

K051013SPINEMED S200B/S200C

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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