The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Titanium Low Profile Screws.
| Device ID | K991807 |
| 510k Number | K991807 |
| Device Name: | TITANIUM LOW PROFILE SCREWS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-26 |
| Decision Date | 1999-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304703797 | K991807 | 000 |
| 00880304069176 | K991807 | 000 |
| 00880304069183 | K991807 | 000 |
| 00880304069206 | K991807 | 000 |
| 00880304163454 | K991807 | 000 |
| 00880304214088 | K991807 | 000 |
| 00880304510524 | K991807 | 000 |
| 00880304510531 | K991807 | 000 |
| 00880304510890 | K991807 | 000 |
| 00880304515451 | K991807 | 000 |
| 00880304521209 | K991807 | 000 |
| 00880304521216 | K991807 | 000 |
| 00880304532403 | K991807 | 000 |
| 00880304533660 | K991807 | 000 |
| 00880304546028 | K991807 | 000 |
| 00880304546899 | K991807 | 000 |
| 00880304658950 | K991807 | 000 |
| 00880304703780 | K991807 | 000 |
| 00880304069169 | K991807 | 000 |