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FDA 510(k)

ACCELL TBM-R

K-Number: K081817 · 2008-09-24

ApplicantIsotis Orthobiologics, Inc.
Decision Date2008-09-24
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCELL TBM-R is the device name listed in this FDA 510(k) record. The listed applicant is Isotis Orthobiologics, Inc.. It received FDA 510(k) clearance on 2008-09-24 under 510(k) number K081817. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCELL TBM-R?

ACCELL TBM-R is a medical device that received FDA 510(k) clearance on 2008-09-24. The listed applicant is Isotis Orthobiologics, Inc.. The 510(k) number is K081817.

When did ACCELL TBM-R receive FDA 510(k) clearance?

ACCELL TBM-R received FDA 510(k) clearance on 2008-09-24, under 510(k) number K081817.

Who is the listed applicant for ACCELL TBM-R?

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

What is the FDA product code for ACCELL TBM-R?

The FDA product code for ACCELL TBM-R is MBP.

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Other records listing Isotis Orthobiologics, 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.

K091193ACCELL EVO3CK070751ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYK050642ORTHOBLAST II PUTTY AND PASTEK052098CONNEXUS, .5CC, MODEL 023000-005K043573DYNAGRAFT II DENTALK050690CONNEXUS

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Related Devices (Code: MBP)

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.

K242799PliaFX FloLifenet HealthK130703VIVORTE BVFVivorte, Inc.K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.K103742ACCELL EVO3 (FORMERLY ACCELL A2I)Integra Life Sciences

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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