The following data is part of a premarket notification filed by Cross Medical Products, Inc. with the FDA for Pwb Lumbar Laminar Hooks With Set Screws.
| Device ID | K924381 |
| 510k Number | K924381 |
| Device Name: | PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | CROSS MEDICAL PRODUCTS, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, STE. 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf CROSS MEDICAL PRODUCTS, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, STE. 450 Concord, CA 94520 |
| 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 | 1992-08-31 |
| Decision Date | 1993-05-18 |