FDA.reportPublic FDA data

Access & Cavity Creation Kit

Primary DI
30850004171012
Brand
Access & Cavity Creation Kit
Company
Lenoss Medical, Inc.
Model
4.6mm (7G)
Catalog number
100.300
Device description
Single use access and cavity creation instrument kit. Kit includes: cavity creator; diamond tip trocar-access cannula assembly; beveled tip trocar-access cannula assembly; bone tamp
Published
2023-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument
OCJSpinal Channeling Instrument, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50850004171016PackageGS13In Commercial Distribution
30850004171012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5085000417101650850004171016
3085000417101230850004171012

GMDN Terms#

Term, Definition table
TermDefinition
Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.6Millimeter

Contacts#

Phone, Email table
PhoneEmail
1-844-553-6677admin@lenoss.com

Regulatory Flags#

DUNS number
066512552
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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