FDA.reportPublic FDA data

Cervical Spacer Inserter

Primary DI
B114213000
Brand
Cervical Spacer Inserter
Company
CALVARY SPINE, LLC
Model
Cervical Spacer Inserter
Catalog number
213-00
Device description
Inserter used for cervical inter-vertebral body spacer placement
Published
2016-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B114213000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
786-301-8006james.r.edw@gmail.com

Regulatory Flags#

DUNS number
832116532
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B11410010Calvary Spine Pedicle Screw System100110012020-11-24
B114155300Calvary Spine Pedicle Screw System15530155302020-11-24
B114155250Calvary Spine Pedicle Screw System15525155252020-11-24
B114155350Calvary Spine Pedicle Screw System15535155452020-11-24
B114155400Calvary Spine Pedicle Screw System15540155402020-11-24
B114155450Calvary Spine Pedicle Screw System15545155452020-11-24
B114155500Calvary Spine Pedicle Screw System15550155502020-11-24
B114155550Calvary Spine Pedicle Screw System15555155552020-11-24
B114155600Calvary Spine Pedicle Screw System15560155602020-11-24
B114165300Calvary Spine Pedicle Screw System16530165302020-11-24
B114165350Calvary Spine Pedicle Screw System16535165352020-11-24
B114165400Calvary Spine Pedicle Screw System16540165402020-11-24
B114165450Calvary Spine Pedicle Screw System16545165452020-11-24
B114165500Calvary Spine Pedicle Screw System16550165502020-11-24
B114165550Calvary Spine Pedicle Screw System16555165552020-11-24
B114165600Calvary Spine Pedicle Screw System16560165602020-11-24
B114175400Calvary Spine Pedicle Screw System17540175402020-11-24
B114175450Calvary Spine Pedicle Screw System17545175452020-11-24
B114175600Calvary Spine Pedicle Screw System17560175602020-11-24
B114185300Calvary Spine Pedicle Screw System18530185302020-11-24

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Primary DI, Brand, Company table
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00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
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B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
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