The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Tt Metal Back Glenoid.
| Device ID | K133349 |
| 510k Number | K133349 |
| Device Name: | SMR TT METAL BACK GLENOID |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne, IN 46814 |
| Contact | Stephen Peoples |
| Correspondent | Stephen Peoples LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne, IN 46814 |
| Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-30 |
| Decision Date | 2014-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390119498 | K133349 | 000 |
| 08033390095143 | K133349 | 000 |
| 08033390095136 | K133349 | 000 |
| 08033390089586 | K133349 | 000 |
| 08033390089579 | K133349 | 000 |
| 08033390089562 | K133349 | 000 |
| 08033390087902 | K133349 | 000 |
| 08033390087896 | K133349 | 000 |
| 08033390084437 | K133349 | 000 |
| 08033390084420 | K133349 | 000 |
| 08033390084413 | K133349 | 000 |
| 08033390084406 | K133349 | 000 |
| 08033390084390 | K133349 | 000 |
| 08033390084383 | K133349 | 000 |
| 08033390094887 | K133349 | 000 |
| 08033390094870 | K133349 | 000 |
| 08033390196123 | K133349 | 000 |
| 08033390253574 | K133349 | 000 |
| 08033390095150 | K133349 | 000 |
| 08033390095167 | K133349 | 000 |
| 08033390119481 | K133349 | 000 |
| 08033390119474 | K133349 | 000 |
| 08033390119467 | K133349 | 000 |
| 08033390094863 | K133349 | 000 |
| 08033390094856 | K133349 | 000 |
| 08033390095297 | K133349 | 000 |
| 08033390095280 | K133349 | 000 |
| 08033390095273 | K133349 | 000 |
| 08033390095266 | K133349 | 000 |
| 08033390095259 | K133349 | 000 |
| 08033390095242 | K133349 | 000 |
| 08033390095235 | K133349 | 000 |
| 08033390095228 | K133349 | 000 |
| 08033390095204 | K133349 | 000 |
| 08033390095198 | K133349 | 000 |
| 08033390095181 | K133349 | 000 |
| 08033390095174 | K133349 | 000 |
| 08033390253567 | K133349 | 000 |