The following data is part of a premarket notification filed by Renovis Surgical Technologies, Llc with the FDA for Renovis Tesera Trabecular Technology (t3) Acetabular Shell System.
| Device ID | K132312 |
| 510k Number | K132312 |
| Device Name: | RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | RENOVIS SURGICAL TECHNOLOGIES, LLC 200 Homer Ave Ashland, MA 01721 |
| Contact | Sharyn Orton, Ph.d. |
| Correspondent | Sharyn Orton, Ph.d. RENOVIS SURGICAL TECHNOLOGIES, LLC 200 Homer Ave Ashland, MA 01721 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-25 |
| Decision Date | 2014-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841523103980 | K132312 | 000 |
| 00841523104000 | K132312 | 000 |
| 00841523103997 | K132312 | 000 |
| 00841523103973 | K132312 | 000 |
| 00841523103959 | K132312 | 000 |
| 00841523103942 | K132312 | 000 |
| 00841523103935 | K132312 | 000 |
| 00841523103928 | K132312 | 000 |
| 00841523103904 | K132312 | 000 |
| 00841523103898 | K132312 | 000 |
| 00841523103881 | K132312 | 000 |
| 00841523104017 | K132312 | 000 |
| 00841523104024 | K132312 | 000 |
| 00841523103966 | K132312 | 000 |
| 00841523103911 | K132312 | 000 |
| 00841523104109 | K132312 | 000 |
| 00841523104093 | K132312 | 000 |
| 00841523104086 | K132312 | 000 |
| 00841523104079 | K132312 | 000 |
| 00841523104062 | K132312 | 000 |
| 00841523104055 | K132312 | 000 |
| 00841523104048 | K132312 | 000 |
| 00841523104031 | K132312 | 000 |
| 00841523103874 | K132312 | 000 |