FDA.reportPublic FDA data

Anjon Bremer Halo System

Primary DI
10810592030463
Brand
Anjon Bremer Halo System
Company
ANJON HOLDINGS LLC
Model
Skull Pin Accessory Pack, Standard 59mm, 10/pk
Catalog number
P410
Device description
Anjon Bremer Halo System Skull Pin, Standard 59mm, 10/pk
Published
2018-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JECComponent, Traction, Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171863000Anjon Bremer Halo SystemAnjon Holdings, LLC2018-03-19JEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810592030463PrimaryGS10
00810592030015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081059203046310810592030463
00810592030015008105920300158105920300150810592030015

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-877-430-8690info@generixmedical.com

Regulatory Flags#

DUNS number
080902221
Device count
10
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810592030289Anjon Bremer Halo SystemRing Set Accessory PackARA12018-04-20
10810592030333Anjon Bremer Halo SystemPediatric Ring Set Accessory PackPRA12018-04-20
10810592030456Anjon Bremer Halo SystemCrown Set Accessory PackHCA12018-04-20
10810592030470Anjon Bremer Halo SystemTorque Limit Knobs, 8/pkSPA12018-04-20
10810592030487Anjon Bremer Halo SystemTorque Limit Knobs, 4/pkLPA12018-04-20
10810592030500Anjon Bremer Halo SystemSkull Pin, Standard 59mm, 5/pkP452018-04-20
10810592030517Anjon Bremer Halo SystemSkull Pin, Long 71mm, 2/pkP522018-04-20
00810592030701Anjon Bremer Halo System7/16 OPEN END WRENCH2020-05-21
00810592030497Anjon Bremer Halo SystemPediatric Halo Skull Pins 10 Non-Sterile1000172020-04-01
00810592030558Anjon Bremer Halo SystemSmall Adjustable Ring Sterile1000562020-04-01
00810592030565Anjon Bremer Halo SystemLarge Halo Crown Sterile1000552020-04-01
00810592030572Anjon Bremer Halo SystemSmall Halo Crown Sterile1000542020-04-01
00810592030589Anjon Bremer Halo SystemMayfield Adaptor Set Ant/Post - Molded Crown1000532020-04-01
00810592030596Anjon Bremer Halo SystemCutting Tip Halo Skull Pins 5 Sterile1000522020-04-01
00810592030602Anjon Bremer Halo SystemExtra Long Halo Skull Pins 2 Sterile1000512020-04-01
00810592030619Anjon Bremer Halo SystemStandard Halo Skull Pins 5 Sterile1000502020-04-01
00810592030626Anjon Bremer Halo SystemPediatric Halo Skull Pins 10 Sterile1000492020-04-01
00810592030640Anjon Bremer Halo SystemLarge Pediatric Ring Sterile1000472020-04-01
00810592030657Anjon Bremer Halo SystemSmall Pediatric Ring Sterile1000462020-04-01
00810592030664Anjon Bremer Halo SystemLarge Adjustable Ring Sterile 1000452020-04-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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