The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Tibial Insert.
| Device ID | K963028 |
| 510k Number | K963028 |
| Device Name: | TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashley M Bock |
| Correspondent | Ashley M Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912117401 | K963028 | 000 |
| 00888912117203 | K963028 | 000 |
| 00888912117197 | K963028 | 000 |
| 00888912117173 | K963028 | 000 |
| 00888912117166 | K963028 | 000 |
| 00888912117159 | K963028 | 000 |
| 00888912117135 | K963028 | 000 |
| 00888912117128 | K963028 | 000 |
| 00888912117111 | K963028 | 000 |
| 00888912117104 | K963028 | 000 |
| 00888912117098 | K963028 | 000 |
| 00888912117081 | K963028 | 000 |
| 00888912117074 | K963028 | 000 |
| 00888912117067 | K963028 | 000 |
| 00888912117050 | K963028 | 000 |
| 00888912117043 | K963028 | 000 |
| 00888912117210 | K963028 | 000 |
| 00888912117227 | K963028 | 000 |
| 00888912117234 | K963028 | 000 |
| 00888912117395 | K963028 | 000 |
| 00888912117388 | K963028 | 000 |
| 00888912117371 | K963028 | 000 |
| 00888912117364 | K963028 | 000 |
| 00888912117357 | K963028 | 000 |
| 00888912117340 | K963028 | 000 |
| 00888912117326 | K963028 | 000 |
| 00888912117319 | K963028 | 000 |
| 00888912117302 | K963028 | 000 |
| 00888912117296 | K963028 | 000 |
| 00888912117289 | K963028 | 000 |
| 00888912117272 | K963028 | 000 |
| 00888912117265 | K963028 | 000 |
| 00888912117258 | K963028 | 000 |
| 00888912117241 | K963028 | 000 |
| 00888912117036 | K963028 | 000 |