The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Johnson And Johnson Power System.
| Device ID | K913629 |
| 510k Number | K913629 |
| Device Name: | JOHNSON AND JOHNSON POWER SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-15 |
| Decision Date | 1991-11-13 |