FDA.reportPublic FDA data

L.I.F.A. Burrs

Primary DI
04251944146484
Brand
L.I.F.A. Burrs
Company
MAXXOS - Medical GmbH
Model
MI24720-165
Catalog number
MI24720-165
Device description
L.I.F.A Shannon Recta Burr Ø2,0mm x 13mm, L: 70mm
Published
2026-04-10
Public version status
New
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
HTTBurr, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251892000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251892000MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH2025-09-08HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251944146484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251944146484042519441464844251944146484

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4915141807283info@maxxos-medical.com

Regulatory Flags#

DUNS number
313262497
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251944101667P.A.C.E.M113128-0082025-12-14
04251944101674P.A.C.E.M113128-0102025-12-14
04251944101681P.A.C.E.M113128-0122025-12-14
04251944101698P.A.C.E.M113128-0162025-12-14
04251944101704P.A.C.E.M113128-0182025-12-14
04251944101711P.A.C.E.M113128-0202025-12-14
04251944101728P.A.C.E.M113128-0222025-12-14
04251944101735P.A.C.E.M113128-0242025-12-14
04251944101742P.A.C.E.M113128-0262025-12-14
04251944101759P.A.C.E.M113128-0282025-12-14
04251944101766P.A.C.E.M113128-0302025-12-14
04251944101773P.A.C.E.M112128-0082025-12-14
04251944101780P.A.C.E.M112128-0102025-12-14
04251944101797P.A.C.E.M112128-0122025-12-14
04251944101803P.A.C.E.M112128-0142025-12-14
04251944101810P.A.C.E.M112128-0162025-12-14
04251944101827P.A.C.E.M112128-0182025-12-14
04251944101834P.A.C.E.M112128-0202025-12-14
04251944101841P.A.C.E.M112128-0222025-12-14
04251944101858P.A.C.E.M112128-0242025-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809288930007IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930014IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930021IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930038IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930045IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930052IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930069IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930076IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930083IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930090IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930106IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930113IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930120IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930137IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930144IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930151IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930168IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930175IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930182IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930199IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930205IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930212IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930229IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930236IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930243IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930250IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930267IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930274IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930281IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930298IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13