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

FDA 510(k)

BKS Revision Sleeves System

K-Number: K181569 · 2018-10-12

ApplicantOrtho Development Corporation
Decision Date2018-10-12
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BKS Revision Sleeves System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181569. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BKS Revision Sleeves System?

BKS Revision Sleeves System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Ortho Development Corporation. The 510(k) number is K181569.

When did BKS Revision Sleeves System receive FDA 510(k) clearance?

BKS Revision Sleeves System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181569.

Who is the listed applicant for BKS Revision Sleeves System?

The FDA 510(k) record lists Ortho Development Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BKS Revision Sleeves System?

The FDA product code for BKS Revision Sleeves System is JWH.

Other records listing Ortho Development Corporation 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.

K253161Balanced Knee System TriMax Porous Femoral ComponentsK251052Trivicta® Hip StemK242984BKS Revision SystemK242833Legend® Acetabular ShellK233758Trivicta™ Hip StemK233093Balanced Knee® System TriMax PS Plus Tibial Insert

View all 18 devices →

Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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.

↑