DJO SURGICAL
GUDID 00888912085366
LINER, ACETABULAR, FMP, HOODED, 20D 32XMP10 CM
DJO, LLC
Non-constrained polyethylene acetabular liner| Primary Device ID | 00888912085366 |
| NIH Device Record Key | 8570c867-e661-4db9-83c6-4fe8ec539d9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DJO SURGICAL |
| Version Model Number | 433-32-210 |
| Company DUNS | 081840873 |
| Company Name | DJO, LLC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888912085366 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K973119
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 | 2016-05-25 |
On-Brand Devices [DJO SURGICAL]
| 00888912143707 | HEAD, HUMERAL W/OFFSET FEMALE TAPER, 42X27 O/S |
| 00888912115414 | SAMPLE, B/P 3D N/P LSZ6 |
| 00888912115162 | BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE3R |
| 00888912115070 | BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE3L |
| 00888912111140 | SAMPLE, FEMUR N/P SZ6L 3D KNEE |
| 00888912085656 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP12 CM |
| 00888912085649 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP11 CM |
| 00888912085632 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP10 CM |
| 00888912085618 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP9 CM |
| 00888912085601 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP8 CM |
| 00888912085595 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP7 CM |
| 00888912085588 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP6 CM |
| 00888912085571 | LINER, ACETABULAR, FMP, HOODED, 10D +5 28XMP5 CM |
| 00888912084734 | LINER, ACETABULAR, FMP, HOODED, 10D 22XMP3 CM |
| 00888912084727 | LINER, ACETABULAR, FMP, HOODED, 10D 22XMP2 CM |
| 00888912084710 | LINER, ACETABULAR, FMP, HOODED, 10D 22XMP1 CM |
| 00888912077330 | SHELL, BIPOLAR, MODULAR, ENCORE, SIZE41 |
| 00888912077279 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE56 |
| 00888912077262 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE54 |
| 00888912077248 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE52 |
| 00888912077231 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE51 |
| 00888912077217 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE50 |
| 00888912077194 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE48 |
| 00888912077163 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE46 |
| 00888912077132 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE44 |
| 00888912077118 | SHELL, BIPOLAR, MODULAR, ENCORE SIZE42 |
| 00888912076562 | 32mm FEMORAL HEAD, -5mm |
| 00888912076555 | 32mm FEMORAL HEAD, +10mm |
| 00888912076548 | 32mm FEMORAL HEAD, +5mm |
| 00888912076531 | 28mm FEMORAL HEAD, OTI, -5mm |
| 00888912076524 | 28mm FEMORAL HEAD, +10mm |
| 00888912076517 | 28mm FEMORAL HEAD, +5mm |
| 00888912076500 | 28mm FEMORAL HEAD, NEUTRAL |
| 00888912023382 | 32mm FEMORAL HEAD, NEUTRAL |
| 00888912111065 | STEM, MODULAR, FEMORAL CEMENTED 10X150 |
| 00888912429788 | TRL/LINER+5,MP1,22,10HD |
| 00888912429658 | TRIAL LINER+5,MP1,22 NEUTRAL |
| 00888912428781 | TRIAL, LINER 22 X 10 X MP12 |
| 00888912419499 | FOUNDATION PRIMARY TIBIAL INSERT TRIAL, SIZE 2, 19MM |
| 00888912419482 | FOUNDATION PRIMARY TIBIAL INSERT TRIAL, SIZE 2, 15MM |
| 00888912419475 | FOUNDATION PRIMARY TIBIAL INSERT TRIAL, SIZE 2, 13MM |
| 00888912419468 | FOUNDATION PRIMARY TIBIAL INSERT TRIAL, SIZE 2, 11MM |
| 00888912419451 | FOUNDATION PRIMARY TIBIAL INSERT TRIAL, SIZE 2, 9MM |
| 00888912418874 | FOUNDATION P.S. TIBIAL INSERT TRIAL, SIZE 12, 19MM |
| 00888912418867 | FOUNDATION P.S. TIBIAL INSERT TRIAL, SIZE 12, 15MM |
| 00888912418850 | FOUNDATION P.S. TIBIAL INSERT TRIAL, SIZE 12, 13MM |
| 00888912418843 | FOUNDATION P.S. TIBIAL INSERT TRIAL, SIZE 12, 11MM |
| 00888912418836 | FOUNDATION P.S. TIBIAL INSERT TRIAL, SIZE 12, 9MM |
| 00888912418829 | FOUNDATION P.S. TIBIAL INSERT TRIAL, SIZE 10, 19MM |
| 00888912418812 | FOUNDATION P.S. TIBIAL INSERT TRIAL, SIZE 10, 15MM |
Trademark Results [DJO SURGICAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DJO SURGICAL 87172951 5146803 Live/Registered |
ENCORE MEDICAL, L.P. 2016-09-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.