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FDA 510(k)

BIO-MINI REVO SUTURE ANCHOR

K-Number: K053561 · 2006-02-23

ApplicantConmed Linvatec
Decision Date2006-02-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO-MINI REVO SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Linvatec. It received FDA 510(k) clearance on 2006-02-23 under 510(k) number K053561. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-MINI REVO SUTURE ANCHOR?

BIO-MINI REVO SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2006-02-23. The listed applicant is Conmed Linvatec. The 510(k) number is K053561.

When did BIO-MINI REVO SUTURE ANCHOR receive FDA 510(k) clearance?

BIO-MINI REVO SUTURE ANCHOR received FDA 510(k) clearance on 2006-02-23, under 510(k) number K053561.

Who is the listed applicant for BIO-MINI REVO SUTURE ANCHOR?

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

What is the FDA product code for BIO-MINI REVO SUTURE ANCHOR?

The FDA product code for BIO-MINI REVO SUTURE ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing Conmed Linvatec as applicant

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.

K111779Y-KNOT ALL-SUTURE ANCHOR MODEL HF13K102410MATRYX INTERFERENCE SCREW (5.0-6.5MM)K102339CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICEK101100CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503K092898CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURESK090560CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS

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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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