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FDA 510(k)

SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM

K-Number: K983873 · 1998-12-30

ApplicantSyntec Scientific Corp.
Decision Date1998-12-30
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM 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 1998-12-30 under 510(k) number K983873. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM?

SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Syntec Scientific Corp.. The 510(k) number is K983873.

When did SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM receive FDA 510(k) clearance?

SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM received FDA 510(k) clearance on 1998-12-30, under 510(k) number K983873.

Who is the listed applicant for SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM?

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 DHS/DCS PLATE SYSTEM?

The FDA product code for SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM is KTT.

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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.

K111189SYNTEC DENTAL IMPLANTK101971SYNTEC OS SPINAL FIXATION SYSTEMK092889SYNTEC OSTEO-PLATE AND SCREW FIXATIONK090476SYNTEC ORTHODONTIC MINI SCREWK090839MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTSK984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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