Locking Plates

Primary DI
00842188101496
Brand
Locking Plates
Company
Trimed, INC.
Model
SMTP-6
Catalog number
SMTP-6
Device description
Semi-Tubular Plate, 6-Hole
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K243999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243999000TriMed Ankle Fixation SystemTriMed, Inc.2025-03-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188101496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188101496008421881014968421881014960842188101496

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

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188100864Locking PlatesPS12PS122016-09-07
00842188100871Locking PlatesPS15PS152016-09-07
00842188100895Hook PlatesHOOK-4HOOK-42016-09-07
00842188100901Hook PlatesHOOK-6HOOK-62016-09-07
00842188100918Hook PlatesHOOK-8HOOK-82016-09-07
00842188100925Hook PlatesHOOK-10HOOK-102016-09-07
00842188100932Hook PlatesHOOK-12HOOK-122016-09-07
00842188101366SideWinder Fracture PlatesSWOL-6MSWOL-6M2016-09-07
00842188101373SideWinder Fracture PlatesSWOL-6NSWOL-6N2016-09-07
00842188101380SideWinder Fracture PlatesSWOL-6WSWOL-6W2016-09-07
00842188101397SideWinder Fracture PlatesSWOL-7MSWOL-7M2016-09-07
00842188101403SideWinder Fracture PlatesSWOL-7NSWOL-7N2016-09-07
00842188101410SideWinder Fracture PlatesSWOL-7WSWOL-7W2016-09-07
00842188101427SideWinder Fracture PlatesSWOR-6MSWOR-6M2016-09-07
00842188101434SideWinder Fracture PlatesSWOR-6NSWOR-6N2016-09-07
00842188101441SideWinder Fracture PlatesSWOR-6WSWOR-6W2016-09-07
00842188101458SideWinder Fracture PlatesSWOR-7MSWOR-7M2016-09-07
00842188101465SideWinder Fracture PlatesSWOR-7NSWOR-7N2016-09-07
00842188101472SideWinder Fracture PlatesSWOR-7WSWOR-7W2016-09-07
00842188101489Locking PlatesSMTP-3SMTP-32016-09-07

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