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FDA 510(k)

BIOSET XCH

K-Number: K072238 · 2008-01-25

ApplicantRegeneration Technologies, Inc.
Decision Date2008-01-25
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOSET XCH 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 2008-01-25 under 510(k) number K072238. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSET XCH?

BIOSET XCH is a medical device that received FDA 510(k) clearance on 2008-01-25. The listed applicant is Regeneration Technologies, Inc.. The 510(k) number is K072238.

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

BIOSET XCH received FDA 510(k) clearance on 2008-01-25, under 510(k) number K072238.

Who is the listed applicant for BIOSET XCH?

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 XCH?

The FDA product code for BIOSET XCH is MQV.

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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 PASTK072327CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTONK063584STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937K060180BIOSET XCK060253STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.K052405STERLING INTERFERENC SCREW HT

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Related Devices (Code: MQV)

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

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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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