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FDA 510(k)

ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD

K-Number: K993873 · 2000-01-03

ApplicantAlphatec Mfg., Inc.
Decision Date2000-01-03
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Mfg., Inc.. It received FDA 510(k) clearance on 2000-01-03 under 510(k) number K993873. 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 ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD?

ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD is a medical device that received FDA 510(k) clearance on 2000-01-03. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K993873.

When did ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD receive FDA 510(k) clearance?

ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD received FDA 510(k) clearance on 2000-01-03, under 510(k) number K993873.

Who is the listed applicant for ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD?

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

What is the FDA product code for ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD?

The FDA product code for ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD is KTT.

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Other records listing Alphatec Mfg., Inc. as applicant

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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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