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FDA 510(k)

BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

K-Number: K971139 · 1997-06-25

ApplicantBoston Scientific Corp
Decision Date1997-06-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K971139. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT?

BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Boston Scientific Corp. The 510(k) number is K971139.

When did BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT receive FDA 510(k) clearance?

BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT received FDA 510(k) clearance on 1997-06-25, under 510(k) number K971139.

Who is the listed applicant for BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT?

The FDA product code for BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT is MBI.

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Related Devices (Code: MBI)

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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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