The following data is part of a premarket notification filed by Innovate Orthopaedics Limited with the FDA for Quick-start Screws.
| Device ID | K212547 |
| 510k Number | K212547 |
| Device Name: | Quick-Start Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Innovate Orthopaedics Limited 3M Buckley Innovation Centre Firth Street Huddersfield, GB Hd1 3bd |
| Contact | Alex Gutteridge |
| Correspondent | Alex Gutteridge Innovate Orthopaedics Limited 3M Buckley Innovation Centre Firth Street Huddersfield, GB Hd1 3bd |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-13 |
| Decision Date | 2021-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060464140310 | K212547 | 000 |
| 05060464140143 | K212547 | 000 |
| 05060464140136 | K212547 | 000 |
| 05060464140129 | K212547 | 000 |
| 05060464140112 | K212547 | 000 |
| 05060464140105 | K212547 | 000 |
| 05060464140099 | K212547 | 000 |
| 05060464140082 | K212547 | 000 |
| 05060464140075 | K212547 | 000 |
| 05060464140068 | K212547 | 000 |
| 05060464140051 | K212547 | 000 |
| 05060464140044 | K212547 | 000 |
| 05060464140037 | K212547 | 000 |
| 05060464140020 | K212547 | 000 |
| 05060464140150 | K212547 | 000 |
| 05060464140167 | K212547 | 000 |
| 05060464140303 | K212547 | 000 |
| 05060464140297 | K212547 | 000 |
| 05060464140280 | K212547 | 000 |
| 05060464140273 | K212547 | 000 |
| 05060464140327 | K212547 | 000 |
| 05060464140242 | K212547 | 000 |
| 05060464140235 | K212547 | 000 |
| 05060464140228 | K212547 | 000 |
| 05060464140211 | K212547 | 000 |
| 05060464140204 | K212547 | 000 |
| 05060464140198 | K212547 | 000 |
| 05060464140181 | K212547 | 000 |
| 05060464140174 | K212547 | 000 |
| 05060464140013 | K212547 | 000 |