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FDA 510(k)

FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5

K-Number: K081060 · 2008-12-24

ApplicantCore Essence Orthopaedics, LLC
Decision Date2008-12-24
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 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 2008-12-24 under 510(k) number K081060. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5?

FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 is a medical device that received FDA 510(k) clearance on 2008-12-24. The listed applicant is Core Essence Orthopaedics, LLC. The 510(k) number is K081060.

When did FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 receive FDA 510(k) clearance?

FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 received FDA 510(k) clearance on 2008-12-24, under 510(k) number K081060.

Who is the listed applicant for FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5?

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 FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5?

The FDA product code for FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 is GAQ.

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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.

K071477REVERTO 55 AND 37 SHAPE MEMORY STAPLESK071520RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X

Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.K082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek IncorporatedK063603SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated

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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