Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

REDAPT Blade Augments

K-Number: K190847 · 2019-10-25

ApplicantSmith & Nephew, Inc.
Decision Date2019-10-25
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REDAPT Blade Augments is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2019-10-25 under approval number K190847. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDAPT Blade Augments?

REDAPT Blade Augments is a medical device that received FDA 510(k) clearance on 2019-10-25. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K190847.

When was REDAPT Blade Augments approved by the FDA?

REDAPT Blade Augments received FDA 510(k) clearance on 2019-10-25, under approval number K190847.

What company makes REDAPT Blade Augments?

REDAPT Blade Augments is manufactured by Smith & Nephew, Inc..

What is the FDA product code for REDAPT Blade Augments?

The FDA product code for REDAPT Blade Augments is LPH.

Other Devices by Smith & Nephew, Inc.

K163086VLP MINI-MOD 2.0mm Column Plates K161233OXINIUM DH Fermoral Heads K161264TRIGEN Low Profile Bone Screws K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device K162078EVOS Small Fragment Plating System K160923REDAPT Anteverted Cemented Liner

View all 107 devices →

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

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.

↑