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FDA 510(k)

ORTHOLOC 3DSI LOCKING SCREWS

K-Number: K113339 · 2011-12-12

ApplicantWrightmedicaltechnologyinc
Decision Date2011-12-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOLOC 3DSI LOCKING SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2011-12-12 under 510(k) number K113339. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOLOC 3DSI LOCKING SCREWS?

ORTHOLOC 3DSI LOCKING SCREWS is a medical device that received FDA 510(k) clearance on 2011-12-12. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K113339.

When did ORTHOLOC 3DSI LOCKING SCREWS receive FDA 510(k) clearance?

ORTHOLOC 3DSI LOCKING SCREWS received FDA 510(k) clearance on 2011-12-12, under 510(k) number K113339.

Who is the listed applicant for ORTHOLOC 3DSI LOCKING SCREWS?

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

What is the FDA product code for ORTHOLOC 3DSI LOCKING SCREWS?

The FDA product code for ORTHOLOC 3DSI LOCKING SCREWS is HRS.

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Related Devices (Code: HRS)

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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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