The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Modula Options For Severe Bone Loss And Trauma.
| Device ID | K964350 |
| 510k Number | K964350 |
| Device Name: | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Shavawn Paraduhn |
| Correspondent | Shavawn Paraduhn INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JDI |
| Subsequent Product Code | KRO |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1997-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024247765 | K964350 | 000 |