The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics High Tibial Osteotomy System.
| Device ID | K892228 |
| 510k Number | K892228 |
| Device Name: | INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-05 |
| Decision Date | 1989-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024172210 | K892228 | 000 |
| 00889024172067 | K892228 | 000 |
| 00889024172081 | K892228 | 000 |
| 00889024172098 | K892228 | 000 |
| 00889024172104 | K892228 | 000 |
| 00889024172111 | K892228 | 000 |
| 00889024172128 | K892228 | 000 |
| 00889024172135 | K892228 | 000 |
| 00889024172142 | K892228 | 000 |
| 00889024172159 | K892228 | 000 |
| 00889024172166 | K892228 | 000 |
| 00889024172173 | K892228 | 000 |
| 00889024172180 | K892228 | 000 |
| 00889024172197 | K892228 | 000 |
| 00889024172203 | K892228 | 000 |
| 00889024259508 | K892228 | 000 |