FDA.reportPublic FDA data

Locking HEX Screw 3.2mm

Primary DI
00842188126659
Brand
Locking HEX Screw 3.2mm
Company
Trimed, INC.
Model
LHEX3.2-36
Catalog number
LHEX3.2-36
Device description
Locking Hex Screw 3.2, 36mm
Published
2023-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222637000TriMed Wrist Fixation System 3TriMed, Inc.2022-12-21HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188126659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188126659008421881266598421881266590842188126659

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188131981CannCompScrew 2.0mm (SelfDrill)L2026L20262026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)L2028L20282026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)L2030L20302026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)L2032L20322026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)L2034L20342026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)L2036L20362026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)L2038L20382026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)L2040L20402026-06-02
00842188121678CannCompScrew 1.7mm (SelfDrill)L1707L17072021-01-11
00842188121685CannCompScrew 2.3mm (SelfDrill)L2311L23112021-01-11
00842188121692CannCompScrew 2.3mm (SelfDrill)L2313L23132021-01-11
00842188121708CannCompScrew 2.3mm (SelfDrill)L2315L23152021-01-11
00842188121715CannCompScrew 2.3mm (SelfDrill)L2317L23172021-01-11
00842188121722CannCompScrew 2.3mm (SelfDrill)L2319L23192021-01-11
00842188121746CannCompScrew 3.0mm (SelfDrill)L3011L30112021-01-11
00842188121753CannCompScrew 3.0mm (SelfDrill)L3013L30132021-01-11
00842188121760CannCompScrew 3.0mm (SelfDrill)L3015L30152021-01-11
00842188121777CannCompScrew 3.0mm (SelfDrill)L3017L30172021-01-11
00842188121784CannCompScrew 3.0mm (SelfDrill)L3019L30192021-01-11
00842188121791CannCompScrew 3.0mm (SelfDrill)L3027L30272021-01-11

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Primary DI, Brand, Company table
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08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
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08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
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