The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Taps For Resorbable Screws.
| Device ID | K153587 |
| 510k Number | K153587 |
| Device Name: | Taps For Resorbable Screws |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES (USA) PRODUCTS LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2017-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98031111201S0 | K153587 | 000 |
| H98031106101S0 | K153587 | 000 |
| H98031106001S0 | K153587 | 000 |
| H98031105801S0 | K153587 | 000 |
| H98031105601S0 | K153587 | 000 |
| H98031105401S0 | K153587 | 000 |
| H98031104801S0 | K153587 | 000 |
| H98031104601S0 | K153587 | 000 |
| H98031104401S0 | K153587 | 000 |
| H98031103801S0 | K153587 | 000 |
| H98031103701S0 | K153587 | 000 |
| H98031103601S0 | K153587 | 000 |
| H98031103501S0 | K153587 | 000 |
| H98031103401S0 | K153587 | 000 |
| H98031103301S0 | K153587 | 000 |
| H98031103201S0 | K153587 | 000 |
| H98031106201S0 | K153587 | 000 |
| H98031106301S0 | K153587 | 000 |
| H98031111101S0 | K153587 | 000 |
| H98031111001S0 | K153587 | 000 |
| H98031110201S0 | K153587 | 000 |
| H98031110101S0 | K153587 | 000 |
| H98031110001S0 | K153587 | 000 |
| H98031109401S0 | K153587 | 000 |
| H98031109301S0 | K153587 | 000 |
| H98031107301S0 | K153587 | 000 |
| H98031107201S0 | K153587 | 000 |
| H98031107101S0 | K153587 | 000 |
| H98031106901S0 | K153587 | 000 |
| H98031106801S0 | K153587 | 000 |
| H98031106701S0 | K153587 | 000 |
| H98031106501S0 | K153587 | 000 |
| H98031106401S0 | K153587 | 000 |
| H98031103101S0 | K153587 | 000 |