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FDA 510(k)

SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35

K-Number: K120557 · 2012-03-19

ApplicantBiomet Spine & Bone Healing Technologies
Decision Date2012-03-19
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine & Bone Healing Technologies. It received FDA 510(k) clearance on 2012-03-19 under 510(k) number K120557. 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 SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35?

SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 is a medical device that received FDA 510(k) clearance on 2012-03-19. The listed applicant is Biomet Spine & Bone Healing Technologies. The 510(k) number is K120557.

When did SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 receive FDA 510(k) clearance?

SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 received FDA 510(k) clearance on 2012-03-19, under 510(k) number K120557.

Who is the listed applicant for SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35?

The FDA 510(k) record lists Biomet Spine & Bone Healing Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35?

The FDA product code for SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 is OVD.

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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.

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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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