FDA.reportPublic FDA data

12mm Evans Plate

Primary DI
00812926027210
Brand
12mm Evans Plate
Company
Trilliant Surgical, LLC
Model
300-54-212
Published
2017-03-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K130964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130964000GRIDLOCK PLATING SYSTEMTrilliant Surgical, Ltd.2013-05-08HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926027210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926027210008129260272108129260272100812926027210

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
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
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
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00810028393448STAR PSI Tibia Anatomical Model601-01-0012022-11-30
00810028393455STAR PSI Talus Cut Guide601-02-0002022-11-30
00810028393462STAR PSI Talus Anatomical Model601-02-0012022-11-30
00810028394971STAR PSI Standard Bundle with Anatomical Models601-00-0012022-11-30
0081292602720310mm Evans Plate300-54-2102017-03-15
00812926027791Tissue Retractor317-00-0072018-09-23
00812926027869Subtalar Implant System Sterilization Tray Lid112-99-0112018-09-23
0081292602851410 Hole Gridlock Helical Plate, Right300-65-0042018-10-15
00812926027036Tiger210-00-1022018-09-23
00812926027890Tiger210-99-1122018-09-23
00812926028002Gridlock320-99-1132018-09-23
00812926028026Gridlock310-00-0212018-09-23
00190446972020Generic Instrument215-00-0072026-07-16
00190446972037Generic Instrument215-00-0082026-07-16
00190446900498Arsenal Foot330-60-0072026-06-25
00190446900504Arsenal Foot330-60-0082026-06-25
00190446917861Arsenal Foot330-01-2152026-06-25
00190446917878Arsenal Foot330-01-2162026-06-25
00190446932406Arsenal Foot330-22-0132026-06-25

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Primary DI, Brand, Company table
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