FDA.report

MATTA

Primary DI
07613154320455
Brand
MATTA
Company
Stryker Trauma SA
Model
425657S
Catalog number
425657S
Device description
Curved Pelvic Plate R88
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K223772000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223772000PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH2023-04-07HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613154320455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613154320455076131543204557613154320455

GMDN Terms

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; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length106.5Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
481999654
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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