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FDA 510(k)

CRYSTAL

K-Number: K073351 · 2008-01-24

ApplicantSpinal Elements, Inc.
Decision Date2008-01-24
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CRYSTAL is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2008-01-24 under 510(k) number K073351. 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 CRYSTAL?

CRYSTAL is a medical device that received FDA 510(k) clearance on 2008-01-24. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K073351.

When did CRYSTAL receive FDA 510(k) clearance?

CRYSTAL received FDA 510(k) clearance on 2008-01-24, under 510(k) number K073351.

Who is the listed applicant for CRYSTAL?

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

What is the FDA product code for CRYSTAL?

The FDA product code for CRYSTAL is ODP.

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Related Devices (Code: ODP)

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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