FDA.reportPublic FDA data

P.A.C.E.

Primary DI
04251944101810
Brand
P.A.C.E.
Company
MAXXOS - Medical GmbH
Model
M112128-016
Device description
Cortical Screw ø2,8mm, L16mm
Published
2025-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

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
04251944101810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251944101810042519441018104251944101810

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
04251944146484L.I.F.A. BurrsMI24720-165MI24720-1652026-04-10
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
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

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Primary DI, Brand, Company table
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