FDA.reportPublic FDA data

Apelo® / Apelo® MIS

Primary DI
M68120061306250
Brand
Apelo® / Apelo® MIS
Company
ATLAS SPINE, INC.
Model
2006-13-0625
Catalog number
2006-13-0625
Device description
6.5mm Bone Tap
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

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
M68120061306250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(561) 741-1108sales@atlasspine.com

Regulatory Flags#

DUNS number
140801007
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M68111230100070HiJAK™ Stand Alone1123-01-00071123-01-00072020-09-23
M68111230100080HiJAK™ Stand Alone1123-01-00081123-01-00082020-09-23
M68111230100090HiJAK™ Stand Alone1123-01-00091123-01-00092020-09-23
M68111230100100HiJAK™ Stand Alone1123-01-00101123-01-00102020-09-23
M68111230100110HiJAK™ Stand Alone1123-01-00111123-01-00112020-09-23
M68111230100120HiJAK™ Stand Alone1123-01-00121123-01-00122020-09-23
M68111230100130HiJAK™ Stand Alone1123-01-00131123-01-00132020-09-23
M68111230100140HiJAK™ Stand Alone1123-01-00141123-01-00142020-09-23
M68111230200070HiJAK™ Stand Alone1123-02-00071123-02-00072020-09-23
M68111230200080HiJAK™ Stand Alone1123-02-00081123-02-00082020-09-23
M68111230200090HiJAK™ Stand Alone1123-02-00091123-02-00092020-09-23
M68111230200100HiJAK™ Stand Alone1123-02-00101123-02-00102020-09-23
M68111230200110HiJAK™ Stand Alone1123-02-00111123-02-00112020-09-23
M68111230200120HiJAK™ Stand Alone1123-02-00121123-02-00122020-09-23
M68111230200130HiJAK™ Stand Alone1123-02-00131123-02-00132020-09-23
M68111230200140HiJAK™ Stand Alone1123-02-00141123-02-00142020-09-23
M68111230300080HiJAK™ Stand Alone1123-03-00081123-03-00082020-09-23
M68111230300090HiJAK™ Stand Alone1123-03-00091123-03-00092020-09-23
M68111230300100HiJAK™ Stand Alone1123-03-00101123-03-00102020-09-23
M68111230300110HiJAK™ Stand Alone1123-03-00111123-03-00112020-09-23

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