FDA 510(k)

BLACKSTONE PILLAR XL PEEK SPACERS

K-Number: K082235 · 2008-09-04

Decision Date2008-09-04

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BLACKSTONE PILLAR XL PEEK SPACERS is the device name listed in this FDA 510(k) record. The listed applicant is Blackstone Medical, Inc.. It received FDA 510(k) clearance on 2008-09-04 under 510(k) number K082235. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKSTONE PILLAR XL PEEK SPACERS?

BLACKSTONE PILLAR XL PEEK SPACERS is a medical device that received FDA 510(k) clearance on 2008-09-04. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K082235.

When did BLACKSTONE PILLAR XL PEEK SPACERS receive FDA 510(k) clearance?

BLACKSTONE PILLAR XL PEEK SPACERS received FDA 510(k) clearance on 2008-09-04, under 510(k) number K082235.

Who is the listed applicant for BLACKSTONE PILLAR XL PEEK SPACERS?

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

What is the FDA product code for BLACKSTONE PILLAR XL PEEK SPACERS?

The FDA product code for BLACKSTONE PILLAR XL PEEK SPACERS is MAX.

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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.