The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Cls Stem (modification).
| Device ID | K953690 |
| 510k Number | K953690 |
| Device Name: | CLS STEM (MODIFICATION) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Barry J Hassett |
| Correspondent | Barry J Hassett INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1996-06-07 |