The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Dr. Herzberg Disposable External Fixator.
| Device ID | K890989 |
| 510k Number | K890989 |
| Device Name: | DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ORIGIN MEDSYSTEMS, INC. 1900 SOUTH NORFOLK STREET, SUITE 312 San Mateo, CA 94403 |
| Contact | Moll, M.d. |
| Correspondent | Moll, M.d. ORIGIN MEDSYSTEMS, INC. 1900 SOUTH NORFOLK STREET, SUITE 312 San Mateo, CA 94403 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1990-04-05 |