DJO SURGICAL

GUDID 00190446308317

Head, Femoral, CoCr, 28mm, +3.5mm

Encore Medical, L.P.

Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis
Primary Device ID00190446308317
NIH Device Record Key0f38b1de-9018-4907-bb4e-cfd0ce911ac3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDJO SURGICAL
Version Model Number400-00-283
Company DUNS154074504
Company NameEncore Medical, L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]
GS100190446308317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [DJO SURGICAL]

00190446324188EXPRT Revision Hip, Capture Bolt with Poly Plug, 85mm
00190446324171EXPRT Revision Hip, Capture Bolt with Poly Plug, 75mm
00190446324164EXPRT Revision Hip, Capture Bolt with Poly Plug, 65mm
00190446323006ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ16X108MM
00190446322993ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ14X108MM
00190446322986ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ12X108MM
00190446322979ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM
00190446322955ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X108MM
00190446296119ENCORE REVERSE HUMERAL CANAL REAMER, SZ 16
00190446296102ENCORE REVERSE HUMERAL CANAL REAMER, SZ 14
00190446296096ENCORE REVERSE HUMERAL CANAL REAMER, SZ 12
00190446296089ENCORE REVERSE HUMERAL CANAL REAMER, SZ 10
00190446296072ENCORE REVERSE HUMERAL CANAL REAMER, SZ 8
00190446296058ENCORE REVERSE HUMERAL CANAL REAMER, SZ 6
00190446293811ENCORE REVERSE HUMERAL CANAL REAMER, SZ 5
00190446284420AltiVate Anatomic, Pegged Glenoid Trial, Size 54
00190446284413AltiVate Anatomic, Pegged Glenoid Trial, Size 50
00190446284376AltiVate Anatomic, Pegged Glenoid Trial, Size 46
00190446284369AltiVate Anatomic, Pegged Glenoid Trial, Size 42
00190446284352AltiVate Anatomic, Pegged Glenoid Trial, Size 38
00190446281849DJO EMPOWR KNEETM UNIVERSAL TIBIA BASE X-RAY TEMPLATES
00190446281757EMPOWR PS KNEETM INSERT / PREP OUTLIER LARGE 2
00190446281740DJO EMPOWR KNEETM CEMENTED STEM / TIB AUG PREP, LOWER TRAY
00190446281733DJO EMPOWR KNEETM CEMENTED STEM / TIB AUG PREP, UPPER TRAY
00190446281719DJO EMPOWR KNEETM TIBIAL CUT 2, UPPER TRAY
00190446281702EMPOWR VVC KNEETM INSERT TRIAL CORE, LOWER TRAY
00190446281146EMPOWR PS KNEETM INSERT / PREP OUTLIER SMALL 2
00190446278160DJO EMPOWR KNEETM TIBIAL IM 0-3-6 POST SLOPE TOWER
00190446278139DJO EMPOWR KNEETM TIBIAL 2/10 ROTATABLE STYLUS
00190446278115DJO EMPOWR KNEETM TIBIAL 3 DEG SLOPE RESECTION GUIDE 3, LT
00190446278108DJO EMPOWR KNEETM TIBIAL RESECTION GUIDE 3, RIGHT
00190446278092DJO EMPOWR KNEETM TIBIAL RESECTION GUIDE 3, LEFT
00190446278085DJO EMPOWR KNEETM TIBIAL EM ADJUSTABLE PROXIMAL BODY
00190446278078DJO EMPOWR KNEETM TIBIAL EM DISTAL BODY ANKLE CLAMP
00190446278023DJO EMPOWR KNEETM UNIVERSAL TIBIA COUNTER TORQUE WRENCH
00190446276883DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 6BU, 5MM
00190446274407AltiVate Reverse, Small Shell X-Ray Template
00190446272984DJO EMPOWR KNEETM TIBIAL AUGMENT SCREW, 15MM
00190446272977DJO EMPOWR KNEETM TIBIAL AUGMENT SCREW, 10MM
00190446272960DJO EMPOWR KNEETM TIBIAL AUGMENT SCREW, 5MM
00190446272953DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 8BU, 5MM
00190446272946DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 7BU, 5MM
00190446272939DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 11P, 5MM
00190446272922DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 11, 5MM
00190446272915DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 10, 5MM
00190446272908DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 9, 5MM
00190446272892DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 8, 5MM
00190446272885DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 7, 5MM
00190446272878DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 6, 5MM
00190446272861DJO EMPOWR KNEETM TIBIAL AUGMENT, HALF BLOCK, SZ 5, 5MM

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