FDA.report

Sorrento Bone Graft Substitute Strip (10cc)

Primary DI
B064HB11600201
Brand
Sorrento Bone Graft Substitute Strip (10cc)
Company
XENCO MEDICAL LLC
Model
HB-116-0020
Device description
CORRECTION: Sorrento Bone Graft Substitute Strip (20cc) 10cm x 2.5cm x .8cm (20cc), Alphatec Neocore Osteoconductive Matrix 100mm x 25mm x 8mm (20cc)
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B064HB11600201PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone matrix implant, animal-derived, bioabsorbableA sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
858-202-1505sarahdo@xencomedical.com

Regulatory Flags

DUNS number
079282130
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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