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FDA 510(k)

STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)

K-Number: K090986 · 2009-12-30

ApplicantDfine, Inc.
Decision Date2009-12-30
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Dfine, Inc.. It received FDA 510(k) clearance on 2009-12-30 under 510(k) number K090986. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)?

STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) is a medical device that received FDA 510(k) clearance on 2009-12-30. The listed applicant is Dfine, Inc.. The 510(k) number is K090986.

When did STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) receive FDA 510(k) clearance?

STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) received FDA 510(k) clearance on 2009-12-30, under 510(k) number K090986.

Who is the listed applicant for STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)?

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

What is the FDA product code for STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)?

The FDA product code for STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) is NDN.

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Other records listing Dfine, 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.

K091310ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682K072496MODIFICATION TO SPACE CPSXL BONE CEMENTK070351SPACE 360 DELIVERY SYSTEMK061531SPACE CPSXL BONE CEMENT

Related Devices (Code: NDN)

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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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