DJO SURGICAL
GUDID 00190446689812
EMPOWR Acet DM, HEAD TRIAL, THREADED OFFSET SLEEVE, +10.5MM
Encore Medical, L.P.
Acetabulum prosthesis trial, prefabricated, reusable| Primary Device ID | 00190446689812 |
| NIH Device Record Key | 59767fdb-9ca9-43f9-a065-83c0956050f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DJO SURGICAL |
| Version Model Number | 803-15-115 |
| Company DUNS | 154074504 |
| Company Name | Encore Medical, L.P. |
| 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 | false |
| 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 | 00190446689812 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203557
FDA Product Code
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
[00190446689812]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-26 |
| Device Publish Date | 2021-05-18 |
On-Brand Devices [DJO SURGICAL]
| 00190446324188 | EXPRT Revision Hip, Capture Bolt with Poly Plug, 85mm |
| 00190446324171 | EXPRT Revision Hip, Capture Bolt with Poly Plug, 75mm |
| 00190446324164 | EXPRT Revision Hip, Capture Bolt with Poly Plug, 65mm |
| 00190446323006 | ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ16X108MM |
| 00190446322993 | ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ14X108MM |
| 00190446322986 | ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ12X108MM |
| 00190446322979 | ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM |
| 00190446322955 | ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X108MM |
| 00190446296119 | ENCORE REVERSE HUMERAL CANAL REAMER, SZ 16 |
| 00190446296102 | ENCORE REVERSE HUMERAL CANAL REAMER, SZ 14 |
| 00190446296096 | ENCORE REVERSE HUMERAL CANAL REAMER, SZ 12 |
| 00190446296089 | ENCORE REVERSE HUMERAL CANAL REAMER, SZ 10 |
| 00190446296072 | ENCORE REVERSE HUMERAL CANAL REAMER, SZ 8 |
| 00190446296058 | ENCORE REVERSE HUMERAL CANAL REAMER, SZ 6 |
| 00190446293811 | ENCORE REVERSE HUMERAL CANAL REAMER, SZ 5 |
| 00190446284420 | AltiVate Anatomic, Pegged Glenoid Trial, Size 54 |
| 00190446284413 | AltiVate Anatomic, Pegged Glenoid Trial, Size 50 |
| 00190446284376 | AltiVate Anatomic, Pegged Glenoid Trial, Size 46 |
| 00190446284369 | AltiVate Anatomic, Pegged Glenoid Trial, Size 42 |
| 00190446284352 | AltiVate Anatomic, Pegged Glenoid Trial, Size 38 |
| 00190446281849 | DJO EMPOWR KNEETM UNIVERSAL TIBIA BASE X-RAY TEMPLATES |
| 00190446281757 | EMPOWR PS KNEETM INSERT / PREP OUTLIER LARGE 2 |
| 00190446281740 | DJO EMPOWR KNEETM CEMENTED STEM / TIB AUG PREP, LOWER TRAY |
| 00190446281733 | DJO EMPOWR KNEETM CEMENTED STEM / TIB AUG PREP, UPPER TRAY |
| 00190446281719 | DJO EMPOWR KNEETM TIBIAL CUT 2, UPPER TRAY |
| 00190446281702 | EMPOWR VVC KNEETM INSERT TRIAL CORE, LOWER TRAY |
| 00190446281146 | EMPOWR PS KNEETM INSERT / PREP OUTLIER SMALL 2 |
| 00190446278160 | DJO EMPOWR KNEETM TIBIAL IM 0-3-6 POST SLOPE TOWER |
| 00190446278139 | DJO EMPOWR KNEETM TIBIAL 2/10 ROTATABLE STYLUS |
| 00190446278115 | DJO EMPOWR KNEETM TIBIAL 3 DEG SLOPE RESECTION GUIDE 3, LT |
| 00190446278108 | DJO EMPOWR KNEETM TIBIAL RESECTION GUIDE 3, RIGHT |
| 00190446278092 | DJO EMPOWR KNEETM TIBIAL RESECTION GUIDE 3, LEFT |
| 00190446278085 | DJO EMPOWR KNEETM TIBIAL EM ADJUSTABLE PROXIMAL BODY |
| 00190446278078 | DJO EMPOWR KNEETM TIBIAL EM DISTAL BODY ANKLE CLAMP |
| 00190446278023 | DJO EMPOWR KNEETM UNIVERSAL TIBIA COUNTER TORQUE WRENCH |
| 00190446276883 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 6BU, 5MM |
| 00190446274407 | AltiVate Reverse, Small Shell X-Ray Template |
| 00190446272984 | DJO EMPOWR KNEETM TIBIAL AUGMENT SCREW, 15MM |
| 00190446272977 | DJO EMPOWR KNEETM TIBIAL AUGMENT SCREW, 10MM |
| 00190446272960 | DJO EMPOWR KNEETM TIBIAL AUGMENT SCREW, 5MM |
| 00190446272953 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 8BU, 5MM |
| 00190446272946 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 7BU, 5MM |
| 00190446272939 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 11P, 5MM |
| 00190446272922 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 11, 5MM |
| 00190446272915 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 10, 5MM |
| 00190446272908 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 9, 5MM |
| 00190446272892 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 8, 5MM |
| 00190446272885 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 7, 5MM |
| 00190446272878 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 6, 5MM |
| 00190446272861 | DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 5, 5MM |
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 |
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