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FDA 510(k)

ALPHATEC WIRE EXTERNAL FIXATION SYSTEM

K-Number: K980788 · 1998-05-22

ApplicantAlphatec Mfg., Inc.
Decision Date1998-05-22
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHATEC WIRE 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 1998-05-22 under 510(k) number K980788. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHATEC WIRE EXTERNAL FIXATION SYSTEM?

ALPHATEC WIRE EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-22. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K980788.

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

ALPHATEC WIRE EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1998-05-22, under 510(k) number K980788.

Who is the listed applicant for ALPHATEC WIRE 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 WIRE EXTERNAL FIXATION SYSTEM?

The FDA product code for ALPHATEC WIRE EXTERNAL FIXATION SYSTEM is JDW.

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Other records listing Alphatec Mfg., Inc. as applicant

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Related Devices (Code: JDW)

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker 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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