SmartLock 92-50620E

GUDID 07613327459371

SURGEON ID MAND RECON PLATE,S,HEMI,LEFT

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 07613327459371
• NIH Device Record Key: f6b507ef-205f-4348-ba3c-4175b234131a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartLock
• Version Model Number: 92-50620E
• Catalog Number: 92-50620E
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327459371 [Primary]
GS1	37613327459372 [Package]; Package: pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190696

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

[07613327459371]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2019-07-17

On-Brand Devices [SmartLock]

• 07613327462739: LOCKING PLATE, SAGITTAL SPLIT, CURVED
• 07613327462722: LOCKING PLATE, SAGITTAL SPLIT, CURVED
• 07613327462715: LOCKING PLATE, SAGITTAL SPLIT, CURVED
• 07613327462708: LOCKING PLATE, SAGITTAL SPLIT, CURVED
• 07613327460650: PRIMARY FULL MAND PLATE,W.TEMPLATE
• 07613327460643: PRIMARY FULL MAND PLATE,W.TEMPLATE
• 07613327460506: LOCKING PLATE,SAG.SPLIT,WITH TAB
• 07613327417876: LOCKING PLATE,SAGIT. SPLIT,STR
• 07613327417869: LOCKING PLATE,SAGIT. SPLIT,STR
• 07613327417852: LOCKING PLATE,SAGIT. SPLIT,STR
• 07613252450696: LOCKING PLATE,SAGIT.SPLIT,CVD.,14MM BAR
• 07613252267706: LOCKING L-PLATE,W. 5MM BAR,9 HOLE,90¿
• 07613252237006: LOCKING PLATE,SAGIT.SPLIT,CVD.,4MM BAR
• 07613252236993: LOCKING PLATE,SAGIT.SPLIT,CVD.,10MM BAR
• 07613252236986: LOCKING PLATE,SAGIT.SPLIT,CVD.,7MM BAR
• 07613252236979: LOCKING PLATE,SAGIT. SPLIT,STR,4MM BAR
• 07613252236962: LOCKING PLATE,SAGIT. SPLIT,STR,7MM BAR
• 07613252236955: LOCKING PLATE,SAGIT.SPLIT,STR,10MM BAR
• 07613154748037: Locking Screw, emergency, Cross-Pin
• 07613154732456: ANCHOR PLATE,LOCKING,T-SHAPE,SHORT,6MM
• 07613154732289: LOCKING PLATE, CURVED, MIDFACE
• 07613154731954: ANCHOR PLATE,LOCKING,STRAIGHT,SHORT,6MM
• 07613154681686: MAND. LOCKING PLATE,STR.,3MM BAR
• 07613154676224: LOCKING SCREW,EMERGENCY,CROSS-PIN
• 07613154676217: LOCKING SCREW,EMERGENCY,CROSS-PIN
• 07613154676200: LOCKING SCREW,EMERGENCY,CROSS-PIN
• 07613154676194: LOCKING SCREW,EMERGENCY,CROSS-PIN
• 07613154676187: LOCKING SCREW,EMERGENCY,CROSS-PIN
• 07613154676170: LOCKING SCREW,EMERGENCY,CROSS-PIN
• 07613154676163: LOCKING SCREW,EMERGENCY,CROSS-PIN
• 07613154674107: LOCKING L-PLATE, WITH BAR, MIDFACE
• 07613154647705: LOCKING T-PLATE,WITH BAR,MIDFACE
• 07613154647385: LOCKING SCREW, CROSS-PIN
• 07613154647378: LOCKING SCREW, CROSS-PIN
• 07613154647361: LOCKING SCREW, CROSS-PIN
• 07613154647309: LOCKING SCREW, CROSS-PIN
• 07613154647293: LOCKING SCREW, CROSS-PIN
• 07613154647286: LOCKING SCREW, CROSS-PIN
• 07613154647279: LOCKING SCREW, CROSS-PIN
• 07613154647262: LOCKING SCREW, CROSS-PIN
• 07613154647255: LOCKING SCREW, CROSS-PIN
• 07613154647248: LOCKING SCREW, CROSS-PIN
• 07613154647231: LOCKING SCREW, CROSS-PIN
• 07613154647125: LOCKING SCREW,CROSS-PIN,SELF-TAPPING
• 07613154647118: LOCKING SCREW,CROSS-PIN,SELF-TAPPING
• 07613154647101: LOCKING SCREW,CROSS-PIN,SELF-TAPPING
• 07613154643745: Locking Screw, Cross-Pin
• 07613154643738: LOCKING SCREW, CROSS-PIN
• 07613154643721: LOCKING SCREW, CROSS-PIN
• 07613154643714: LOCKING SCREW, CROSS-PIN