ISOTIS ORTHOBIOLOGICS, INC

Contract manufacturer · Irvine, CA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration

2090010 (openFDA record; or search FDA's registration database)

FEI number

3001503333

Registered for

FDA registration year 2026

Establishment types

Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer

Owner or operator

SeaSpine Orthopedics Corporation (FDA owner/operator no. 10049589)

Registered address

2 Goodyear, Irvine, CA 92618

Contract listings

3 device listings, 1 product codes, first listed Jun 24, 2015

Certification

Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.