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FDA 510(k)

BIOSET XC

K-Number: K060180 · 2006-09-06

ApplicantRegeneration Technologies, Inc.
Decision Date2006-09-06
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOSET XC is the device name listed in this FDA 510(k) record. The listed applicant is Regeneration Technologies, Inc.. It received FDA 510(k) clearance on 2006-09-06 under 510(k) number K060180. 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 BIOSET XC?

BIOSET XC is a medical device that received FDA 510(k) clearance on 2006-09-06. The listed applicant is Regeneration Technologies, Inc.. The 510(k) number is K060180.

When did BIOSET XC receive FDA 510(k) clearance?

BIOSET XC received FDA 510(k) clearance on 2006-09-06, under 510(k) number K060180.

Who is the listed applicant for BIOSET XC?

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

What is the FDA product code for BIOSET XC?

The FDA product code for BIOSET XC is MBP.

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Other records listing Regeneration Technologies, 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.

K080418REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PASTK072238BIOSET XCHK072327CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTONK063584STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937K060253STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.K052405STERLING INTERFERENC SCREW HT

View all 11 devices →

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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