The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Orthosorb(tm) Absorbable Cement Restrictor.
| Device ID | K932595 |
| 510k Number | K932595 |
| Device Name: | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Contact | Caroline Lee |
| Correspondent | Caroline Lee JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-28 |
| Decision Date | 1994-09-20 |