FDA.reportPublic FDA data

P.A.C.E.

Primary DI
04251944144602
Brand
P.A.C.E.
Company
MAXXOS - Medical GmbH
Model
M211117-407
Device description
P.A.C.E. MTP Fusion Plate, comp. 10°, Long, Right
Published
2025-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, 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
04251944144602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251944144602042519441446024251944144602

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01