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FDA 510(k)

SPINEMED S200B/S200C

K-Number: K051013 · 2005-04-27

ApplicantCert Health Sciences, LLC
Decision Date2005-04-27
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPINEMED S200B/S200C 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 2005-04-27 under 510(k) number K051013. 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 S200B/S200C?

SPINEMED S200B/S200C is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Cert Health Sciences, LLC. The 510(k) number is K051013.

When did SPINEMED S200B/S200C receive FDA 510(k) clearance?

SPINEMED S200B/S200C received FDA 510(k) clearance on 2005-04-27, under 510(k) number K051013.

Who is the listed applicant for SPINEMED S200B/S200C?

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 S200B/S200C?

The FDA product code for SPINEMED S200B/S200C 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.

K030060SPINEMED

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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