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FDA 510(k)

BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR

K-Number: K983186 · 1998-10-21

ApplicantLinvatec Corp.
Decision Date1998-10-21
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K983186. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR?

BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Linvatec Corp.. The 510(k) number is K983186.

When did BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR receive FDA 510(k) clearance?

BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR received FDA 510(k) clearance on 1998-10-21, under 510(k) number K983186.

Who is the listed applicant for BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR?

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

What is the FDA product code for BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR?

The FDA product code for BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR is MAI.

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Other records listing Linvatec Corp. as applicant

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Related Devices (Code: MAI)

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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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