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FDA 510(k)

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)

K-Number: K121693 · 2012-12-27

ApplicantSapphire Medical Group, Inc.
Decision Date2012-12-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) is the device name listed in this FDA 510(k) record. The listed applicant is Sapphire Medical Group, Inc.. It received FDA 510(k) clearance on 2012-12-27 under 510(k) number K121693. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)?

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) is a medical device that received FDA 510(k) clearance on 2012-12-27. The listed applicant is Sapphire Medical Group, Inc.. The 510(k) number is K121693.

When did A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) receive FDA 510(k) clearance?

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) received FDA 510(k) clearance on 2012-12-27, under 510(k) number K121693.

Who is the listed applicant for A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)?

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

What is the FDA product code for A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)?

The FDA product code for A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) is MAX.

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Related Devices (Code: MAX)

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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