The following data is part of a premarket notification filed by Boston Brace Intl., Inc. with the FDA for Static Cranioplasty Orthosis.
| Device ID | K063098 |
| 510k Number | K063098 |
| Device Name: | STATIC CRANIOPLASTY ORTHOSIS |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | BOSTON BRACE INTL., INC. 20 LEDIN DR. Avon, MA 02322 |
| Contact | James Wynne |
| Correspondent | James Wynne BOSTON BRACE INTL., INC. 20 LEDIN DR. Avon, MA 02322 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2007-04-11 |
| Summary: | summary |