The following data is part of a premarket notification filed by Bio-medical Prosthetics with the FDA for Stuart Cd Universal Rod Connector Clamps.
| Device ID | K894702 |
| 510k Number | K894702 |
| Device Name: | STUART CD UNIVERSAL ROD CONNECTOR CLAMPS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | BIO-MEDICAL PROSTHETICS 5600 SILVER OAK CT. Rockville, MD 20855 |
| Contact | Abe Glasser |
| Correspondent | Abe Glasser BIO-MEDICAL PROSTHETICS 5600 SILVER OAK CT. Rockville, MD 20855 |
| 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 | 1989-07-27 |
| Decision Date | 1989-10-11 |