FDA.reportPublic FDA data

Non-Spanning Wrist Fusion

Primary DI
00842188132230
Brand
Non-Spanning Wrist Fusion
Company
Trimed, INC.
Model
NSFL-STD
Catalog number
NSFL-STD
Device description
Non-Spanning Wrist Fusion, Lt, Standard BND
Published
2026-08-17
Public version status
New
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
K262032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262032000TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.2026-07-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188132230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188132230008421881322308421881322300842188132230

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
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
00842188101328Total Wrist Fusion PlatesRFP-STDRFP-STD2016-09-07
00842188101335Total Wrist Fusion PlatesRFP-SHBRFP-SHB2016-09-07
00842188101342Total Wrist Fusion PlatesRFP-STRRFP-STR2016-09-07
00842188105210Cancellous Screw 3.8mmCAB3.8-10CAB3.8-102016-09-07
00842188105227Cancellous Screw 3.8mmCAB3.8-12CAB3.8-122016-09-07
00842188105234Cancellous Screw 3.8mmCAB3.8-14CAB3.8-142016-09-07
00842188105241Cancellous Screw 3.8mmCAB3.8-16CAB3.8-162016-09-07
00842188105258Cancellous Screw 3.8mmCAB3.8-18CAB3.8-182016-09-07
00842188105265Cancellous Screw 3.8mmCAB3.8-20CAB3.8-202016-09-07
00842188105272Cancellous Screw 3.8mmCAB3.8-22CAB3.8-222016-09-07
00842188105289Cancellous Screw 3.8mmCAB3.8-24CAB3.8-242016-09-07
00842188105296Cancellous Screw 3.8mmCAB3.8-26CAB3.8-262016-09-07
00842188105302Cancellous Screw 3.8mmCAB3.8-28CAB3.8-282016-09-07
00842188105319Cancellous Screw 3.8mmCAB3.8-30CAB3.8-302016-09-07
00842188105326Cancellous Screw 3.8mmCAB3.8-32CAB3.8-322016-09-07
00842188105333Cancellous Screw 3.8mmCAB3.8-34CAB3.8-342016-09-07
00842188105340Cancellous Screw 3.8mmCAB3.8-36CAB3.8-362016-09-07
00842188105357Cancellous Screw 3.8mmCAB3.8-38CAB3.8-382016-09-07
00842188105364Cancellous Screw 3.8mmCAB3.8-40CAB3.8-402016-09-07
00842188121739CannCompScrew 2.3mm (SelfDrill)L2327L23272021-01-11

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Primary DI, Brand, Company table
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