The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Spinal Concepts, Inc., Universal Bone Plate System Ii.
| Device ID | K973586 |
| 510k Number | K973586 |
| Device Name: | SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II |
| Classification | Screw, Fixation, Bone |
| Applicant | SPINAL CONCEPTS, INC. 820O CAMERON RD., SUITE B-160 Austin, TX 78754 |
| Contact | Teena M Augostino |
| Correspondent | Teena M Augostino SPINAL CONCEPTS, INC. 820O CAMERON RD., SUITE B-160 Austin, TX 78754 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1997-11-07 |
| Summary: | summary |