The following data is part of a premarket notification filed by Scientific Spinal Ltd. with the FDA for Edwards Adjustable Connectors.
Device ID | K915672 |
510k Number | K915672 |
Device Name: | EDWARDS ADJUSTABLE CONNECTORS |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | SCIENTIFIC SPINAL LTD. SCHOOL OF MEDICINE DEPTMENT OF SURGERY Baltimore, MD 21201 |
Contact | Charles C Edwards |
Correspondent | Charles C Edwards SCIENTIFIC SPINAL LTD. SCHOOL OF MEDICINE DEPTMENT OF SURGERY Baltimore, MD 21201 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-17 |
Decision Date | 1993-05-26 |