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FDA 510(k)

BIOMET ANTERIOR LUMBAR PLATE

K-Number: K082187 · 2008-11-13

ApplicantEbi, L.P.
Decision Date2008-11-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET ANTERIOR LUMBAR PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2008-11-13 under 510(k) number K082187. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET ANTERIOR LUMBAR PLATE?

BIOMET ANTERIOR LUMBAR PLATE is a medical device that received FDA 510(k) clearance on 2008-11-13. The listed applicant is Ebi, L.P.. The 510(k) number is K082187.

When did BIOMET ANTERIOR LUMBAR PLATE receive FDA 510(k) clearance?

BIOMET ANTERIOR LUMBAR PLATE received FDA 510(k) clearance on 2008-11-13, under 510(k) number K082187.

Who is the listed applicant for BIOMET ANTERIOR LUMBAR PLATE?

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

What is the FDA product code for BIOMET ANTERIOR LUMBAR PLATE?

The FDA product code for BIOMET ANTERIOR LUMBAR PLATE is KWQ.

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Other records listing Ebi, L.P. 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.

K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMK100220POLARIS SPINAL SYSTEMK093880PEANUT GROWTH CONTROL PLATING SYSTEMK092574ESL SPINAL SYSTEMK093057BIOMET VISION FOOTRING SYSTEMK092336C-THRU SPINAL SYSTEM

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Related Devices (Code: KWQ)

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.

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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.

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