The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Plus Cancellous Bone Screws.
| Device ID | K011719 |
| 510k Number | K011719 |
| Device Name: | PLUS CANCELLOUS BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Contact | Hartmut Loch, Rac |
| Correspondent | Hartmut Loch, Rac PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996033038 | K011719 | 000 |