FDA.reportPublic FDA data

Anjon Bremer Halo System

Primary DI
10810592030289
Brand
Anjon Bremer Halo System
Company
ANJON HOLDINGS LLC
Model
Ring Set Accessory Pack
Catalog number
ARA1
Device description
Anjon Bremer Halo System Ring Set Accessory Pack
Published
2018-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10810592030289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081059203028910810592030289

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

Contacts#

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

Regulatory Flags#

DUNS number
080902221
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810592030333Anjon Bremer Halo SystemPediatric Ring Set Accessory PackPRA12018-04-20
10810592030456Anjon Bremer Halo SystemCrown Set Accessory PackHCA12018-04-20
10810592030463Anjon Bremer Halo SystemSkull Pin Accessory Pack, Standard 59mm, 10/pkP4102018-04-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277681231MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681248MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681255MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681262MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681279MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681286MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681293MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681309MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681316MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681323MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681330MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681347MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681354MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277680463MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680616MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681026MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681071MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681392MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680456MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680470MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680487MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680494MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680500MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680517MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680524MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680531MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680548MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680555MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680562MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680579MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29