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FDA 510(k)

MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM

K-Number: K023498 · 2002-11-13

ApplicantBlackstone Medical, Inc.
Decision Date2002-11-13
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM 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 2002-11-13 under 510(k) number K023498. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM?

MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K023498.

When did MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2002-11-13, under 510(k) number K023498.

Who is the listed applicant for MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM?

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 MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM?

The FDA product code for MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM is KWP.

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Other records listing Blackstone Medical, 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.

K093926FIREBIRD SPINAL FIXATION SYSTEMK100614HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATESK092624FIREBIRD SPINAL FIXATION SYSTEMK082797BLACKSTONE PEDICLE SCREW SYSTEMK081684BLACKSTONE PEDICLE SCREW SYSTEMK082235BLACKSTONE PILLAR XL PEEK SPACERS

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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