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FDA 510(k)

ECTRA II LIGAMENT RELEASE SYSTEM

K-Number: K954627 · 1995-12-18

ApplicantSmith & Nephew Dyonics, Inc.
Decision Date1995-12-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ECTRA II LIGAMENT RELEASE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Dyonics, Inc.. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K954627. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ECTRA II LIGAMENT RELEASE SYSTEM?

ECTRA II LIGAMENT RELEASE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Smith & Nephew Dyonics, Inc.. The 510(k) number is K954627.

When did ECTRA II LIGAMENT RELEASE SYSTEM receive FDA 510(k) clearance?

ECTRA II LIGAMENT RELEASE SYSTEM received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954627.

Who is the listed applicant for ECTRA II LIGAMENT RELEASE SYSTEM?

The FDA 510(k) record lists Smith & Nephew Dyonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECTRA II LIGAMENT RELEASE SYSTEM?

The FDA product code for ECTRA II LIGAMENT RELEASE SYSTEM is HRX.

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Other records listing Smith & Nephew Dyonics, 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.

K955914LIMITED REUSE ARTHROSCOPIC BLADESK954989DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADESK953695DYONICS DISPOSABLE ARTHROSCOPIC BLADESK953387ECTRA LIGAMENT RELEASE SYSTEMK945182DYONICS FIXATION SCREWSK936071SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

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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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