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FDA 510(k)

STABLELOC II EXTERNAL FIXATOR

K-Number: K965029 · 1997-02-19

ApplicantAcu Med, Inc.
Decision Date1997-02-19
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STABLELOC II EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1997-02-19 under 510(k) number K965029. 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 STABLELOC II EXTERNAL FIXATOR?

STABLELOC II EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1997-02-19. The listed applicant is Acu Med, Inc.. The 510(k) number is K965029.

When did STABLELOC II EXTERNAL FIXATOR receive FDA 510(k) clearance?

STABLELOC II EXTERNAL FIXATOR received FDA 510(k) clearance on 1997-02-19, under 510(k) number K965029.

Who is the listed applicant for STABLELOC II EXTERNAL FIXATOR?

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

What is the FDA product code for STABLELOC II EXTERNAL FIXATOR?

The FDA product code for STABLELOC II EXTERNAL FIXATOR is JEC.

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Other records listing Acu Med, 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.

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Related Devices (Code: JEC)

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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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