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FDA 510(k)

SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE

K-Number: K911837 · 1991-11-15

ApplicantAcufex Microsurgical, Inc.
Decision Date1991-11-15
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1991-11-15 under 510(k) number K911837. 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 SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE?

SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1991-11-15. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K911837.

When did SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE receive FDA 510(k) clearance?

SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE received FDA 510(k) clearance on 1991-11-15, under 510(k) number K911837.

Who is the listed applicant for SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE?

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

What is the FDA product code for SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE?

The FDA product code for SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE is JDR.

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Other records listing Acufex Microsurgical, Inc. 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

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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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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