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FDA 510(k)

CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC

K-Number: K003028 · 2000-11-24

ApplicantOsteogenics Biomedical, Inc.
Decision Date2000-11-24
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics Biomedical, Inc.. It received FDA 510(k) clearance on 2000-11-24 under 510(k) number K003028. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC?

CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC is a medical device that received FDA 510(k) clearance on 2000-11-24. The listed applicant is Osteogenics Biomedical, Inc.. The 510(k) number is K003028.

When did CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC receive FDA 510(k) clearance?

CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC received FDA 510(k) clearance on 2000-11-24, under 510(k) number K003028.

Who is the listed applicant for CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC?

The FDA 510(k) record lists Osteogenics Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC?

The FDA product code for CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC is NBY.

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Other records listing Osteogenics Biomedical, Inc. as applicant

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Related Devices (Code: NBY)

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.

K231277TissueStatDurastat, LLCK192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit SuturesK180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami SurgicalK181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech CorporationK180630PTFE SURGICAL SUTUREOmnia Spa

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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