FDA 510(k)

AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM

K-Number: K083311 · 2009-03-04

Decision Date2009-03-04

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, Inc.. It received FDA 510(k) clearance on 2009-03-04 under 510(k) number K083311. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM?

AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-04. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K083311.

When did AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM receive FDA 510(k) clearance?

AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM received FDA 510(k) clearance on 2009-03-04, under 510(k) number K083311.

Who is the listed applicant for AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM?

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

What is the FDA product code for AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM?

The FDA product code for AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM is ODP.

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Other records listing Aesculap Implant Systems, Inc. as applicant

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Related Devices (Code: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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.