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FDA 510(k)

ALPHATEC EXTERNAL FIXATION SYSTEM

K-Number: K964400 · 1997-04-28

ApplicantAlphatec Mfg., Inc.
Decision Date1997-04-28
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHATEC EXTERNAL FIXATION SYSTEM 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 1997-04-28 under 510(k) number K964400. 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?

ALPHATEC EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-28. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K964400.

When did ALPHATEC EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

ALPHATEC EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1997-04-28, under 510(k) number K964400.

Who is the listed applicant for ALPHATEC EXTERNAL FIXATION SYSTEM?

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?

The FDA product code for ALPHATEC EXTERNAL FIXATION SYSTEM 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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