RESTORIS 160126

GUDID 00848486020064

MCK BASEPLATE TEMPLATE (SIZE 6 LM/RL)

MAKO SURGICAL CORP.

Surgical implant template, reusable

• Primary Device ID: 00848486020064
• NIH Device Record Key: 67b4563e-9231-415e-8acd-1a95a862e344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORIS
• Version Model Number: 160126
• Catalog Number: 160126
• Company DUNS: 175239677
• Company Name: MAKO SURGICAL CORP.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486020064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082172

FDA Product Code

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

Sterilization

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

[00848486020064]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [RESTORIS]

• 00848486023508: FEMORAL 1.75 INCH HEADED PIN
• 00848486023461: MCK PATELLA SIZING GUIDE (38mm/41mm)
• 00848486023454: MCK PATELLA SIZING GUIDE (26mm/29mm)
• 00848486022013: OFFSET CUP IMPACTOR
• 00848486021870: STRAIGHT CUP IMPACTOR
• 00848486021641: HIP OFFSET CUP IMPACTOR (TJO)
• 00848486020644: MCK ONLAY INSERT EXTRACTOR
• 00848486020378: MCK PATELLA RESECTION CLAMP
• 00848486020323: MCK PEG DRILL (FEMORAL)
• 00848486020316: MCK GOELET RETRACTOR
• 00848486020309: MCK FEMORAL TEMPLATE (SIZE 7 RM/LL)
• 00848486020293: MCK FEMORAL TEMPLATE (SIZE 6 RM/LL)
• 00848486020286: MCK FEMORAL TEMPLATE (SIZE 5 RM/LL)
• 00848486020279: MCK FEMORAL TEMPLATE (SIZE 4 RM/LL)
• 00848486020262: MCK FEMORAL TEMPLATE (SIZE 3 RM/LL)
• 00848486020255: MCK FEMORAL TEMPLATE (SIZE 2 RM/LL)
• 00848486020248: MCK FEMORAL TEMPLATE (SIZE 1 RM/LL)
• 00848486020231: MCK FEMORAL TEMPLATE (SIZE 8 LM/RL)
• 00848486020224: MCK FEMORAL TEMPLATE (SIZE 7 LM/RL)
• 00848486020217: MCK FEMORAL TEMPLATE (SIZE 6 LM/RL)
• 00848486020200: MCK FEMORAL TEMPLATE (SIZE 5 LM/RL)
• 00848486020194: MCK FEMORAL TEMPLATE (SIZE 4 LM/RL)
• 00848486020187: MCK FEMORAL TEMPLATE (SIZE 3 LM/RL)
• 00848486020170: MCK FEMORAL TEMPLATE (SIZE 2 LM/RL)
• 00848486020163: MCK FEMORAL TEMPLATE (SIZE 1 LM/RL)
• 00848486020156: Tibial Baseplate Template Std RM/LL Sz8
• 00848486020149: MCK BASEPLATE TEMPLATE (SIZE 7 RM/LL)
• 00848486020132: MCK BASEPLATE TEMPLATE (SIZE 6 RM/LL)
• 00848486020125: MCK BASEPLATE TEMPLATE (SIZE 5 RM/LL)
• 00848486020118: MCK BASEPLATE TEMPLATE (SIZE 4 RM/LL)
• 00848486020101: Tibial Baseplate Template Std RM/LL Sz3
• 00848486020095: MCK BASEPLATE TEMPLATE (SIZE 2 RM/LL)
• 00848486020088: MCK BASEPLATE TEMPLATE (SIZE 1 RM/LL)
• 00848486020071: MCK BASEPLATE TEMPLATE (SIZE 7 LM/RL)
• 00848486020064: MCK BASEPLATE TEMPLATE (SIZE 6 LM/RL)
• 00848486020057: MCK BASEPLATE TEMPLATE (SIZE 5 LM/RL)
• 00848486020040: MCK BASEPLATE TEMPLATE (SIZE 4 LM/RL)
• 00848486020033: MCK BASEPLATE TEMPLATE (SIZE 3 LM/RL)
• 00848486020026: MCK BASEPLATE TEMPLATE (SIZE 2 LM/RL)
• 00848486020019: MCK PF TEMPLATE (8 RIGHT)
• 00848486020002: MCK PF TEMPLATE (7 RIGHT)
• 00848486019990: MCK PF TEMPLATE (6 RIGHT)
• 00848486019983: MCK PF TEMPLATE (5 RIGHT)
• 00848486019976: MCK PF TEMPLATE (4 RIGHT)
• 00848486019969: MCK PF TEMPLATE (3 RIGHT)
• 00848486019952: MCK PF TEMPLATE (2 RIGHT)
• 00848486019945: MCK PF TEMPLATE (8 LEFT)
• 00848486019938: MCK PF TEMPLATE (7 LEFT)
• 00848486019921: MCK PF TEMPLATE (6 LEFT)
• 00848486019914: MCK PF TEMPLATE (5 LEFT)