Affiniti™ EH²
GUDID 00846832002245
TORNIER, INC.
Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis| Primary Device ID | 00846832002245 |
| NIH Device Record Key | f58d7b51-25d9-4caf-ac90-552c24a8f521 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affiniti™ EH² |
| Version Model Number | 0020084 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 56 Millimeter |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 56 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832002245 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073331
FDA Product Code
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Affiniti™ EH²]
| 00846832002252 | 0020085 |
| 00846832002245 | 0020084 |
| 00846832002238 | 0020083 |
| 00846832002221 | 0020082 |
| 00846832002214 | 0020081 |
| 00846832002207 | 0020080 |
| 00846832002191 | 0020079 |
| 00846832002184 | 0020078 |
Trademark Results [Affiniti]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFINITI 97477382 not registered Live/Pending |
SuperLayer Labs Management, LLC 2022-06-27 |
 AFFINITI 97044570 not registered Live/Pending |
Halyard MD Opco, LLC 2021-09-24 |
 AFFINITI 85514563 not registered Dead/Abandoned |
KATZ, Steven 2012-01-11 |
AFFINITI 85514563 not registered Dead/Abandoned |
KATZ, Cecile 2012-01-11 |
 AFFINITI 81016986 1016986 Dead/Cancelled |
Wilwood, Inc. 0000-00-00 |
 AFFINITI 79143766 4590914 Live/Registered |
Koninklijke Philips nv 2014-01-22 |
 AFFINITI 77873733 3938734 Live/Registered |
Tornier, Inc. 2009-11-16 |
 AFFINITI 77813762 not registered Dead/Abandoned |
Terrazzo & Marble Supply Co. of IL 2009-08-27 |
 AFFINITI 77593592 not registered Dead/Abandoned |
DATALOGIX, INC. 2008-10-15 |
 AFFINITI 77100548 not registered Dead/Abandoned |
Farberware Licensing Company, LLC 2007-02-06 |
 AFFINITI 76154175 not registered Dead/Abandoned |
Affiniti, Inc. 2000-10-26 |
 AFFINITI 74597990 1928253 Dead/Cancelled |
CIGNA Corporation 1994-11-14 |
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