SMR TT Hybrid Glenoid 1379.59.323
GUDID 08033390122047
Hybrid Glenoid Baseplate Large LOW +3 - Peg L
LIMACORPORATE SPA
Shoulder glenoid fossa prosthesis, prefabricated| Primary Device ID | 08033390122047 |
| NIH Device Record Key | e2ef5f61-097a-44b2-8ec0-14e15eebcd66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMR TT Hybrid Glenoid |
| Version Model Number | 1379.59.323 |
| Catalog Number | 1379.59.323 |
| Company DUNS | 432066322 |
| Company Name | LIMACORPORATE SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033390122047 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163397
FDA Product Code
| PHX | Shoulder Prosthesis, Reverse Configuration |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-05 |
| Device Publish Date | 2024-07-27 |
On-Brand Devices [SMR TT Hybrid Glenoid]
| 08033390122016 | TT Hybrid Glenoid Baseplate Large +2 - Peg L |
| 08033390121996 | TT Hybrid Glenoid Baseplate Large - Peg L |
| 08033390121965 | TT HybHybrid Glenoid Baseplate Large +2 - Peg S |
| 08033390121941 | TT Hybrid Glenoid Baseplate Large - Peg S |
| 08033390121934 | TT Hybrid Glenoid Baseplate Large LOW +2 - Peg L |
| 08033390121903 | TT Hybrid Glenoid Baseplate Large LOW +2 - Peg S |
| 08033390121866 | TT Hybrid Glenoid Baseplate Std +2 - Peg L |
| 08033390121842 | TT Hybrid Glenoid Baseplate Std - Peg L |
| 08033390121811 | TT Hybrid Glenoid Baseplate Std +2 - Peg S |
| 08033390121798 | TT Hybrid Glenoid Baseplate Std - Peg S |
| 08033390121729 | TT Hybrid Glenoid Baseplate Std LOW +2 - Peg L |
| 08033390121705 | TT Hybrid Glenoid Baseplate Std LOW - Peg L |
| 08033390121675 | TT Hybrid Glenoid Baseplate Std LOW +2 - Peg S |
| 08033390121651 | TT Hybrid Glenoid Baseplate Std LOW - Peg S |
| 08033390121620 | TT Hybrid Glenoid Baseplate Small +2 - Peg L |
| 08033390121606 | TT Hybrid Glenoid Baseplate Small - Peg L |
| 08033390121576 | TT Hybrid Glenoid Baseplate Small +2 - Peg S |
| 08033390121552 | TT Hybrid Glenoid Baseplate Small - Peg S |
| 08033390121538 | TT Hybrid Glenoid Baseplate Small LOW +2 - Peg L |
| 08033390121491 | TT Hybrid Glenoid Baseplate Small LOW +2 - Peg S |
| 08033390121118 | TT Hybrid Reverse Baseplate+Screw Std |
| 08033390121002 | TT Hybrid Glenoid Baseplate Small LOW - Peg S |
| 08033390115728 | TT Hybrid Reverse Baseplate+Screw Small |
| 08033390115704 | TT Hybrid Glenoid Baseplate Large LOW - Peg L |
| 08033390115681 | TT Hybrid Glenoid Baseplate Large LOW - Peg S |
| 08033390115674 | TT Hybrid Glenoid Baseplate Small LOW - Peg L |
| 08033390122047 | Hybrid Glenoid Baseplate Large LOW +3 - Peg L |
| 08033390122030 | Hybrid Glenoid Baseplate Large +4 - Peg L |
| 08033390122023 | Hybrid Glenoid Baseplate Large +3 - Peg L |
| 08033390122009 | Hybrid Glenoid Baseplate Large +1 - Peg L |
| 08033390121989 | Hybrid Glenoid Baseplate Large +4 - Peg S |
| 08033390121972 | Hybrid Glenoid Baseplate Large +3 - Peg S |
| 08033390121958 | Hybrid Glenoid Baseplate Large +1 - Peg S |
| 08033390121927 | Hybrid Glenoid Baseplate Large LOW +1 - Peg L |
| 08033390121910 | Hybrid Glenoid Baseplate Large LOW +3 - Peg S |
| 08033390121897 | Hybrid Glenoid Baseplate Large LOW +1 - Peg S |
| 08033390121880 | Hybrid Glenoid Baseplate Std +4 - Peg L |
| 08033390121873 | Hybrid Glenoid Baseplate Std +3 - Peg L |
| 08033390121859 | Hybrid Glenoid Baseplate Std +1 - Peg L |
| 08033390121835 | Hybrid Glenoid Baseplate Std +4 - Peg S |
| 08033390121828 | Hybrid Glenoid Baseplate Std +3 - Peg S |
| 08033390121804 | Hybrid Glenoid Baseplate Std +1 - Peg S |
| 08033390121743 | Hybrid Glenoid Baseplate Std LOW +4 - Peg L |
| 08033390121736 | Hybrid Glenoid Baseplate Std LOW +3 - Peg L |
| 08033390121712 | Hybrid Glenoid Baseplate Std LOW +1 - Peg L |
| 08033390121699 | Hybrid Glenoid Baseplate Std LOW +4 - Peg S |
| 08033390121682 | Hybrid Glenoid Baseplate Std LOW +3 - Peg S |
| 08033390121668 | Hybrid Glenoid Baseplate Std LOW +1 - Peg S |
| 08033390121644 | Hybrid Glenoid Baseplate Small +4 - Peg L |
| 08033390121637 | Hybrid Glenoid Baseplate Small +3 - Peg L |
Trademark Results [SMR TT Hybrid Glenoid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMR TT HYBRID GLENOID 87914421 not registered Live/Pending |
Limacorporate S.P.A. 2018-05-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.