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FDA 510(k)

LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X

K-Number: K082679 · 2009-04-07

ApplicantSintea Biotech, Inc.
Decision Date2009-04-07
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X is the device name listed in this FDA 510(k) record. The listed applicant is Sintea Biotech, Inc.. It received FDA 510(k) clearance on 2009-04-07 under 510(k) number K082679. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X?

LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X is a medical device that received FDA 510(k) clearance on 2009-04-07. The listed applicant is Sintea Biotech, Inc.. The 510(k) number is K082679.

When did LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X receive FDA 510(k) clearance?

LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X received FDA 510(k) clearance on 2009-04-07, under 510(k) number K082679.

Who is the listed applicant for LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X?

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

What is the FDA product code for LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X?

The FDA product code for LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X is JEC.

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Other records listing Sintea Biotech, 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.

K081631SINTEA BIOTECH PLS MULTI-AXIAL SCREWSK072198X-VOID, SPIDERK070181SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XXK060513SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.XK043355SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.XK041989SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X

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Related Devices (Code: JEC)

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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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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