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Certifications, quality policies, and technical documentation that demonstrate execution reliability across every facility.
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ISO 13485:2016 Certification
ISO 13485:2016 quality management system certification across 9 EXALTA facilities. Covers design, development, production, and servicing of medical devices. Certificate FM 701546, valid through July 2028.
View detailsCertifications and Labels
ISO 13485, FDA registration, EU MDR, ANVISA, and J-QMS certifications across EXALTA global facilities.
View detailsCertifications & Registrations
ISO 13485, FDA registration, EU MDR, MDSAP, UKCA, ANVISA, and J-QMS certifications across EXALTA global facilities.
View detailsConflict Minerals Policy
EXALTA commitment to responsible sourcing and compliance with SEC Conflict Minerals Disclosure Rule.
View detailseIFU Directory
Electronic Instructions for Use (eIFU) search portal for EXALTA medical devices.
View detailsPatents and Trademarks
250+ issued patents and registered trademarks held by EXALTA Group and its subsidiaries across orthopedic implants, instruments, and enabling technologies.
View detailsPrivacy Policy
Exalta privacy policy covering information collection, cookies, and data usage.
View detailsFDA Registered Facilities
All EXALTA US manufacturing facilities are registered with the FDA as medical device establishments. 100% of US sites maintain active FDA registration.
View detailsCE Marking (EU MDR)
EU Medical Device Regulation (MDR) QMS certification. Certificate MDR 736847, valid through November 2028. Authorizes EXALTA to manufacture CE-marked medical devices for the European market.
View detailsPurchase Order Terms and Conditions
Standard purchase order terms and conditions governing all purchase orders issued by EXALTA Group.
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