The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Revelation Porous Hip Stem.
| Device ID | K973685 |
| 510k Number | K973685 |
| Device Name: | REVELATION POROUS HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1997-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912080842 | K973685 | 000 |
| 00888912080309 | K973685 | 000 |
| 00888912080293 | K973685 | 000 |
| 00888912080286 | K973685 | 000 |
| 00888912080279 | K973685 | 000 |
| 00888912080262 | K973685 | 000 |
| 00888912080248 | K973685 | 000 |
| 00888912080224 | K973685 | 000 |
| 00888912080217 | K973685 | 000 |
| 00888912080200 | K973685 | 000 |
| 00888912080194 | K973685 | 000 |
| 00888912080187 | K973685 | 000 |
| 00888912080170 | K973685 | 000 |
| 00888912080163 | K973685 | 000 |
| 00888912080156 | K973685 | 000 |
| 00888912080149 | K973685 | 000 |
| 00888912168229 | K973685 | 000 |
| 00888912080316 | K973685 | 000 |
| 00888912080323 | K973685 | 000 |
| 00888912080330 | K973685 | 000 |
| 00888912080835 | K973685 | 000 |
| 00888912080828 | K973685 | 000 |
| 00888912080811 | K973685 | 000 |
| 00888912080804 | K973685 | 000 |
| 00888912080798 | K973685 | 000 |
| 00888912080781 | K973685 | 000 |
| 00888912080439 | K973685 | 000 |
| 00888912080422 | K973685 | 000 |
| 00888912080415 | K973685 | 000 |
| 00888912080408 | K973685 | 000 |
| 00888912080392 | K973685 | 000 |
| 00888912080385 | K973685 | 000 |
| 00888912080378 | K973685 | 000 |
| 00888912080361 | K973685 | 000 |
| 00888912080354 | K973685 | 000 |
| 00888912080347 | K973685 | 000 |
| 00888912168212 | K973685 | 000 |