Shanghai Kinetic Medical Co., Ltd.

Address:2F, No.23 Building, 528 Ruiqing Road,East Zhangjiang Shanghai,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Injector, Vertebroplasty (Does Not Contain Cement) (OAR) (4) Orthopedic Manual Surgical Instrument (LXH) (3) Arthroscope (HRX) (2) Cement, Bone, Vertebroplasty (NDN) (2) Dispenser, Cement (KIH) (1)

Premarket Exempt

No Yes

Clear

KMC Kyphoplasty System - 06938695500137 Catalog Number : FG0005-15

Device Description : KMC Kyphoplasty System consists of four components:Balloon CatheterTool KitPunct KMC Kyphoplasty System consists of four components:Balloon CatheterTool KitPuncture NeedleKMC Medical Balloon Catheter Syringe Pump

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

KMC Kyphoplasty System - 06938695500144 Catalog Number : FG0005-20

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

KMC Vertebral Osteotome - 06938695501059 Catalog Number : VO1101

Device Description : KMC Vertebral Osteotome

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KMC Vertebral Osteotome - 06938695501073 Catalog Number : VO1103

Device Description : KMC Vertebral Osteotome

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KMC Curet - 06938695501172 Catalog Number : FG9001

Device Description : KMC Curet

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Bone Cement Injection Gun - 06938695501295 Catalog Number : SD8101

Device Description : Bone Cement Injection Gun

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

KMC Bone Cement Delivery System - 06938695501486 Catalog Number : FG8210

Device Description : KMC Bone Cement Delivery System

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

KMC Bone Cement Delivery System - 06938695501493 Catalog Number : FG8215

Device Description : KMC Bone Cement Delivery System

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

KMC Bone Cement Delivery System - 06938695501509 Catalog Number : FG8310

Device Description : KMC Bone Cement Delivery System

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

KMC Bone Cement Delivery System - 06938695501516 Catalog Number : FG8315

Device Description : KMC Bone Cement Delivery System

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

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