The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Delta Multihole Tt Pro Acetabular System.
| Device ID | K191622 |
| 510k Number | K191622 |
| Device Name: | Delta Multihole TT Pro Acetabular System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Limacorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Roberto Gabetta |
| Correspondent | Stephen Peoples Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390157490 | K191622 | 000 |
| 08033390151481 | K191622 | 000 |
| 08033390151474 | K191622 | 000 |
| 08033390151467 | K191622 | 000 |
| 08033390151450 | K191622 | 000 |
| 08033390151443 | K191622 | 000 |
| 08033390151436 | K191622 | 000 |
| 08033390151429 | K191622 | 000 |
| 08033390151412 | K191622 | 000 |
| 08033390151405 | K191622 | 000 |
| 08033390151399 | K191622 | 000 |
| 08033390151382 | K191622 | 000 |
| 08033390151207 | K191622 | 000 |
| 08033390151191 | K191622 | 000 |
| 08033390151184 | K191622 | 000 |
| 08033390151498 | K191622 | 000 |
| 08033390157339 | K191622 | 000 |
| 08033390157346 | K191622 | 000 |
| 08033390157483 | K191622 | 000 |
| 08033390157476 | K191622 | 000 |
| 08033390157469 | K191622 | 000 |
| 08033390157452 | K191622 | 000 |
| 08033390157445 | K191622 | 000 |
| 08033390157438 | K191622 | 000 |
| 08033390157421 | K191622 | 000 |
| 08033390157414 | K191622 | 000 |
| 08033390157407 | K191622 | 000 |
| 08033390157391 | K191622 | 000 |
| 08033390157384 | K191622 | 000 |
| 08033390157377 | K191622 | 000 |
| 08033390157360 | K191622 | 000 |
| 08033390157353 | K191622 | 000 |
| 08033390151115 | K191622 | 000 |