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FDA 510(k)

BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE

K-Number: K081849 · 2008-08-28

ApplicantBlackstone Medical, Inc.
Decision Date2008-08-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE 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 2008-08-28 under 510(k) number K081849. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE?

BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K081849.

When did BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE receive FDA 510(k) clearance?

BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE received FDA 510(k) clearance on 2008-08-28, under 510(k) number K081849.

Who is the listed applicant for BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE?

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 SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE?

The FDA product code for BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE is OVD.

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Other records listing Blackstone Medical, Inc. as applicant

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Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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