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FDA 510(k)

RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X

K-Number: K071520 · 2007-08-10

ApplicantCore Essence Orthopaedics, LLC
Decision Date2007-08-10
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X is the device name listed in this FDA 510(k) record. The listed applicant is Core Essence Orthopaedics, LLC. It received FDA 510(k) clearance on 2007-08-10 under 510(k) number K071520. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X?

RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X is a medical device that received FDA 510(k) clearance on 2007-08-10. The listed applicant is Core Essence Orthopaedics, LLC. The 510(k) number is K071520.

When did RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X receive FDA 510(k) clearance?

RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X received FDA 510(k) clearance on 2007-08-10, under 510(k) number K071520.

Who is the listed applicant for RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X?

The FDA 510(k) record lists Core Essence Orthopaedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X?

The FDA product code for RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X is MBI.

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Other records listing Core Essence Orthopaedics, LLC 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.

K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5K071477REVERTO 55 AND 37 SHAPE MEMORY STAPLES

Related Devices (Code: MBI)

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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