Injectable Hydroxyapatite Bone substitute - India CDSCO Medical Device Registration

Injectable Hydroxyapatite Bone substitute is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000383_11ce2176185a1e2b31ad8ada9a7b1fe4_6e151efe626c08c6c63707b77651a938. This device is marketed under the brand name HA. The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Injectable Hydroxyapatite Bone substitute

UID: IMP/MD/2019/000383_11ce2176185a1e2b31ad8ada9a7b1fe4_6e151efe626c08c6c63707b77651a938

Brand Name

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class D

Approving Authority

CDSCO

Product Information

HydroSet® is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (HA). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet® is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. HydroSet® cured in situ provides an open void / gap filler that can augment provisional hardware (HA) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. HydroSet® is a self-setting calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.