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 | K200656 |
| 510k Number | K200656 |
| 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 | Michela Zanotto |
| Correspondent | Lacey Harbour Lima USA Inc. 2001 NE Green Arlington, TX 76006 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-12 |
| Decision Date | 2020-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390151108 | K200656 | 000 |