The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Bone Screw.
| Device ID | K850770 |
| 510k Number | K850770 |
| Device Name: | INTERMEDICS BONE SCREW |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024172067 | K850770 | 000 |
| 00889024172197 | K850770 | 000 |
| 00889024172203 | K850770 | 000 |
| 00889024172210 | K850770 | 000 |
| 00889024365797 | K850770 | 000 |
| 00889024365803 | K850770 | 000 |
| 00889024365810 | K850770 | 000 |
| 00889024365827 | K850770 | 000 |
| 00889024365834 | K850770 | 000 |
| 00889024172180 | K850770 | 000 |
| 00889024172173 | K850770 | 000 |
| 00889024172166 | K850770 | 000 |
| 00889024172081 | K850770 | 000 |
| 00889024172098 | K850770 | 000 |
| 00889024172104 | K850770 | 000 |
| 00889024172111 | K850770 | 000 |
| 00889024172128 | K850770 | 000 |
| 00889024172135 | K850770 | 000 |
| 00889024172142 | K850770 | 000 |
| 00889024172159 | K850770 | 000 |
| 00889024365841 | K850770 | 000 |
| 00889024365858 | K850770 | 000 |
| 00889024365865 | K850770 | 000 |
| 00889024166271 | K850770 | 000 |
| 00889024166288 | K850770 | 000 |
| 00889024166295 | K850770 | 000 |
| 00889024172074 | K850770 | 000 |
| 00889024172227 | K850770 | 000 |
| 00889024172234 | K850770 | 000 |
| 00889024172241 | K850770 | 000 |
| 00889024172258 | K850770 | 000 |
| 00889024166264 | K850770 | 000 |
| 00889024166257 | K850770 | 000 |
| 00889024166240 | K850770 | 000 |
| 00889024365872 | K850770 | 000 |
| 00889024365889 | K850770 | 000 |
| 00889024365896 | K850770 | 000 |
| 00889024166196 | K850770 | 000 |
| 00889024166202 | K850770 | 000 |
| 00889024166219 | K850770 | 000 |
| 00889024166226 | K850770 | 000 |
| 00889024166233 | K850770 | 000 |
| 00889024172265 | K850770 | 000 |