REDAPT 71354254
GUDID 00885556320549
REDAPT ANTEVERTED CEMENTED XLPE ACET 32MM X 56MM
Smith & Nephew, Inc.
Non-constrained polyethylene acetabular liner| Primary Device ID | 00885556320549 |
| NIH Device Record Key | 16078533-9fe6-4e83-9db7-d5ae58d2fbbb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REDAPT |
| Version Model Number | 71354254 |
| Catalog Number | 71354254 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556320549 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160923
FDA Product Code
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
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 | 2016-12-06 |
On-Brand Devices [REDAPT]
| 00885556740859 | REDAPT EXTENDED REAMER REMOVAL CAP |
| 00885556715291 | EXTENDED REAMER QUICK CONNECT |
| 00885556685631 | REDAPT Slice Augment 56MM x 12MM |
| 00885556668733 | REDAPT Slice Augment 50MM X 12MM |
| 00885556657966 | REDAPT MODULAR SHELL 80MM |
| 00885556657959 | REDAPT MODULAR SHELL 78MM |
| 00885556657942 | REDAPT MODULAR SHELL 76MM |
| 00885556657935 | REDAPT MODULAR SHELL 74MM |
| 00885556657928 | REDAPT MODULAR SHELL 72MM |
| 00885556657911 | REDAPT MODULAR SHELL 70MM |
| 00885556657904 | REDAPT MODULAR SHELL 68MM |
| 00885556657898 | REDAPT MODULAR SHELL 66MM |
| 00885556657881 | REDAPT MODULAR SHELL 64MM |
| 00885556657874 | REDAPT MODULAR SHELL 62MM |
| 00885556657867 | REDAPT MODULAR SHELL 60MM |
| 00885556657850 | REDAPT MODULAR SHELL 58MM |
| 00885556657843 | REDAPT MODULAR SHELL 56MM |
| 00885556657836 | REDAPT MODULAR SHELL 54MM |
| 00885556657812 | REDAPT MODULAR SHELL 52MM |
| 00885556657805 | REDAPT MODULAR SHELL 50MM |
| 00885556657799 | REDAPT MODULAR SHELL 48MM |
| 00885556647356 | EXTENDED REAMER REMOVAL CAP |
| 00885556645987 | REDAPT STAPLE AUGMENT TRIAL 50 X 8 |
| 00885556587614 | REDAPT REV ACET STAPLE AUGMENT TRIALS TRAY |
| 00885556587607 | REDAPT REV ACET SLICE AUGMENT TRIALS TRAY |
| 00885556587584 | REDAPT STRAIGHT SHAFT DRILL 50MM |
| 00885556587577 | REDAPT STRAIGHT SHAFT DRILL 35MM |
| 00885556587560 | REDAPT STRAIGHT SHAFT DRILL 25MM |
| 00885556587553 | REDAPT STRAIGHT SHAFT DRILL 15MM |
| 00885556587539 | REDAPT Augment Holding Forceps |
| 00885556586082 | REDAPT STAPLE AUGMENT TRIAL 74 X 24 |
| 00885556586075 | REDAPT STAPLE AUGMENT TRIAL 68 X 24 |
| 00885556586068 | REDAPT STAPLE AUGMENT TRIAL 62 X 24 |
| 00885556586051 | REDAPT STAPLE AUGMENT TRIAL 56 X 24 |
| 00885556586044 | REDAPT STAPLE AUGMENT TRIAL 50 X 24 |
| 00885556586037 | REDAPT STAPLE AUGMENT TRIAL 74 X 18 |
| 00885556586020 | REDAPT STAPLE AUGMENT TRIAL 68 X 18 |
| 00885556586013 | REDAPT STAPLE AUGMENT TRIAL 62 X 18 |
| 00885556586006 | REDAPT STAPLE AUGMENT TRIAL 56 X 18 |
| 00885556585993 | REDAPT STAPLE AUGMENT TRIAL 50 X 18 |
| 00885556585986 | REDAPT STAPLE AUGMENT TRIAL 74 X 12 |
| 00885556585979 | REDAPT STAPLE AUGMENT TRIAL 68 X 12 |
| 00885556585962 | REDAPT STAPLE AUGMENT TRIAL 62 X 12 |
| 00885556585955 | REDAPT STAPLE AUGMENT TRIAL 56 X 12 |
| 00885556585948 | REDAPT STAPLE AUGMENT TRIAL 50 X 12 |
| 00885556585931 | REDAPT STAPLE AUGMENT TRIAL 74 X 8 |
| 00885556585924 | REDAPT STAPLE AUGMENT TRIAL 68 X 8 |
| 00885556585917 | REDAPT STAPLE AUGMENT TRIAL 62 X 8 |
| 00885556585900 | REDAPT STAPLE AUGMENT TRIAL 56 X 8 |
| 00885556585894 | REDAPT SLICE AUGMENT TRIAL 74 X 24 |
Trademark Results [REDAPT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDAPT 88554136 not registered Live/Pending |
Redapt, Inc. 2019-07-31 |
 REDAPT 85571263 4273432 Live/Registered |
Smith & Nephew, Inc. 2012-03-16 |
 REDAPT 85446013 4154083 Live/Registered |
REDAPT, INC. 2011-10-12 |
 REDAPT 85445950 4154080 Live/Registered |
REDAPT, INC. 2011-10-12 |
 REDAPT 76021596 2427146 Dead/Cancelled |
REDAPT SYSTEMS, INC. 2000-04-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.