Certifications and Clearance Gibbstown, NJ ISO 13485:2016 CertificateISO 22716 Certificate Cherry Hill, NJ ISO 13485:2016 Certificate Myerstown, PA ISO 13485:2016 CertificateMDSAP Certificate (ISO 13485:2016)MDD Certifcate FDA Registrations All under Owner Operator 9007845 Gibbstown, NJ 3010002722 Cherry Hill, NJ 2280629 Myerstown, PA 2523320 Delran, NJ 2518690 Health Canada Medical Device Licenses Australian Register of Therapeutic Goods Product Summary KeySplint SoftKeySplint Hard KeyOrtho IBTKeyTrayKeyGuideKeySplint Soft / KeySplint Hard