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FDA 510(k)

SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM

K-Number: K070756 · 2007-06-06

Decision Date2007-06-06
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2007-06-06 under 510(k) number K070756. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM?

SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-06. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K070756.

When did SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM receive FDA 510(k) clearance?

SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM received FDA 510(k) clearance on 2007-06-06, under 510(k) number K070756.

Who is the listed applicant for SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM?

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

What is the FDA product code for SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM?

The FDA product code for SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM is MBL.

Related Clinical Trials

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.

Other records listing Smith & Nephew, 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: MBL)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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