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FDA 510(k)

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS

K-Number: K081631 · 2008-07-18

ApplicantSintea Biotech, Inc.
Decision Date2008-07-18
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS 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 2008-07-18 under 510(k) number K081631. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINTEA BIOTECH PLS MULTI-AXIAL SCREWS?

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Sintea Biotech, Inc.. The 510(k) number is K081631.

When did SINTEA BIOTECH PLS MULTI-AXIAL SCREWS receive FDA 510(k) clearance?

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS received FDA 510(k) clearance on 2008-07-18, under 510(k) number K081631.

Who is the listed applicant for SINTEA BIOTECH PLS MULTI-AXIAL SCREWS?

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 SINTEA BIOTECH PLS MULTI-AXIAL SCREWS?

The FDA product code for SINTEA BIOTECH PLS MULTI-AXIAL SCREWS is MNH. This falls under the ENT category.

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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.

K082679LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.XK072198X-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: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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