DJO SURGICAL

GUDID 00190446318507

INS, KNEE,EMPOWR Partial Knee Tibial Template, Size 6, LM-RL

Encore Medical, L.P.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00190446318507
• NIH Device Record Key: 087a7e22-2984-4c9b-8d98-cd35304fa84f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DJO SURGICAL
• Version Model Number: 801-06-048
• 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	00190446318507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191325

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

[00190446318507]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2020-05-19

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