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FDA 510(k)

REVERTO 55 AND 37 SHAPE MEMORY STAPLES

K-Number: K071477 · 2007-08-15

ApplicantCore Essence Orthopaedics, LLC
Decision Date2007-08-15
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVERTO 55 AND 37 SHAPE MEMORY STAPLES 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 2007-08-15 under 510(k) number K071477. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVERTO 55 AND 37 SHAPE MEMORY STAPLES?

REVERTO 55 AND 37 SHAPE MEMORY STAPLES is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Core Essence Orthopaedics, LLC. The 510(k) number is K071477.

When did REVERTO 55 AND 37 SHAPE MEMORY STAPLES receive FDA 510(k) clearance?

REVERTO 55 AND 37 SHAPE MEMORY STAPLES received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071477.

Who is the listed applicant for REVERTO 55 AND 37 SHAPE MEMORY STAPLES?

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 REVERTO 55 AND 37 SHAPE MEMORY STAPLES?

The FDA product code for REVERTO 55 AND 37 SHAPE MEMORY STAPLES is JDR.

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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 #5K071520RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X

Related Devices (Code: JDR)

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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