The following data is part of a premarket notification filed by Osteotec Ltd with the FDA for Osteotec Silicone Finger Implant.
| Device ID | K140453 |
| 510k Number | K140453 |
| Device Name: | OSTEOTEC SILICONE FINGER IMPLANT |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | OSTEOTEC LTD 9 SILVER BUSINESS PARK, AIRFIELD WAY Christchurch, Dorset, GB Bh23 3ta |
| Contact | Elizabeth Clinton-parker |
| Correspondent | Elizabeth Clinton-parker OSTEOTEC LTD 9 SILVER BUSINESS PARK, AIRFIELD WAY Christchurch, Dorset, GB Bh23 3ta |
| Product Code | KYJ |
| CFR Regulation Number | 888.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2015-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060183090101 | K140453 | 000 |
| 05060183090019 | K140453 | 000 |
| 05060183090026 | K140453 | 000 |
| 05060183090033 | K140453 | 000 |
| 05060183090040 | K140453 | 000 |
| 05060183090057 | K140453 | 000 |
| 05060183090064 | K140453 | 000 |
| 05060183090071 | K140453 | 000 |
| 05060183090088 | K140453 | 000 |
| 05060183090095 | K140453 | 000 |
| 05060183090002 | K140453 | 000 |