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FDA 510(k)

SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE

K-Number: K983988 · 1999-01-27

ApplicantSyntec Scientific Corp.
Decision Date1999-01-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corp.. It received FDA 510(k) clearance on 1999-01-27 under 510(k) number K983988. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE?

SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE is a medical device that received FDA 510(k) clearance on 1999-01-27. The listed applicant is Syntec Scientific Corp.. The 510(k) number is K983988.

When did SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE receive FDA 510(k) clearance?

SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE received FDA 510(k) clearance on 1999-01-27, under 510(k) number K983988.

Who is the listed applicant for SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE?

The FDA 510(k) record lists Syntec Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE?

The FDA product code for SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE is HRS.

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Other records listing Syntec Scientific Corp. 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.

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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