The following data is part of a premarket notification filed by Xiros Plc with the FDA for Poly-tapes With The Fastlok Fixation Device.
| Device ID | K010051 |
| 510k Number | K010051 |
| Device Name: | POLY-TAPES WITH THE FASTLOK FIXATION DEVICE |
| Classification | Staple, Fixation, Bone |
| Applicant | XIROS PLC 28-30 BLENHEIM TERRACE Leeds, GB Ls2 9hd |
| Contact | Jim Rowland |
| Correspondent | Jim Rowland XIROS PLC 28-30 BLENHEIM TERRACE Leeds, GB Ls2 9hd |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-08 |
| Decision Date | 2001-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267130587 | K010051 | 000 |
| 05060267130365 | K010051 | 000 |
| 05060267130372 | K010051 | 000 |
| 05060267130389 | K010051 | 000 |
| 05060267130402 | K010051 | 000 |
| 05060267130433 | K010051 | 000 |
| 05060267130471 | K010051 | 000 |
| 05060267130488 | K010051 | 000 |
| 05060267130495 | K010051 | 000 |
| 05060267130501 | K010051 | 000 |
| 05060267131812 | K010051 | 000 |