The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Reverse Shoulder System.
| Device ID | K110598 |
| 510k Number | K110598 |
| Device Name: | SMR REVERSE SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-02 |
| Decision Date | 2011-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390080637 | K110598 | 000 |
| 08033390113786 | K110598 | 000 |
| 08033390113793 | K110598 | 000 |
| 08033390039048 | K110598 | 000 |
| 08033390039055 | K110598 | 000 |
| 08033390039062 | K110598 | 000 |
| 08033390065214 | K110598 | 000 |
| 08033390065221 | K110598 | 000 |
| 08033390065238 | K110598 | 000 |
| 08033390111546 | K110598 | 000 |
| 08033390099042 | K110598 | 000 |
| 08033390098403 | K110598 | 000 |
| 08033390195300 | K110598 | 000 |
| 08033390194617 | K110598 | 000 |
| 08033390023498 | K110598 | 000 |
| 08033390023511 | K110598 | 000 |
| 08033390038980 | K110598 | 000 |
| 08033390091701 | K110598 | 000 |
| 08033390098373 | K110598 | 000 |
| 08033390098380 | K110598 | 000 |
| 08033390098908 | K110598 | 000 |
| 08033390098915 | K110598 | 000 |
| 08033390046909 | K110598 | 000 |
| 08033390128568 | K110598 | 000 |
| 08033390164368 | K110598 | 000 |
| 08033390023528 | K110598 | 000 |
| 08033390098892 | K110598 | 000 |
| 08033390099035 | K110598 | 000 |
| 08033390120784 | K110598 | 000 |
| 08033390122313 | K110598 | 000 |
| 08033390071772 | K110598 | 000 |
| 08033390071765 | K110598 | 000 |
| 08033390071758 | K110598 | 000 |
| 08033390098922 | K110598 | 000 |
| 08033390132664 | K110598 | 000 |
| 08033390091657 | K110598 | 000 |
| 08033390091664 | K110598 | 000 |
| 08033390091671 | K110598 | 000 |
| 08033390023436 | K110598 | 000 |
| 08033390098250 | K110598 | 000 |
| 08033390071741 | K110598 | 000 |
| 08033390122320 | K110598 | 000 |