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FDA 510(k)

OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM

K-Number: K051656 · 2005-10-25

ApplicantOsteobiologics, Inc.
Decision Date2005-10-25
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteobiologics, Inc.. It received FDA 510(k) clearance on 2005-10-25 under 510(k) number K051656. 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 OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM?

OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-25. The listed applicant is Osteobiologics, Inc.. The 510(k) number is K051656.

When did OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM receive FDA 510(k) clearance?

OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM received FDA 510(k) clearance on 2005-10-25, under 510(k) number K051656.

Who is the listed applicant for OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM?

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

What is the FDA product code for OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM?

The FDA product code for OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM is HRX.

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Other records listing Osteobiologics, Inc. as applicant

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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.

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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.

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