FDA.reportPublic FDA data

Torx Smooth Peg

Primary DI
00842188119781
Brand
Torx Smooth Peg
Company
Trimed, INC.
Model
SPEG1.8-28
Catalog number
SPEG1.8-28
Device description
Torx Smooth Peg 1.8, 28mm
Published
2019-05-07
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
JDSNAIL, FIXATION, BONE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951302000SMALL FRAGMENT PLATES AND SCREWSMedpac1995-05-05JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188119781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188119781008421881197818421881197810842188119781

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
00842188132452Tools - TWFNSF-CADDY-LIDNSF-CADDY-LID2026-08-18
00842188127014Tools - FMSFMS-TRAY-LIDFMS-TRAY-LID2023-04-19
00842188100437Foot PlatesSP20-3SSP20-3S2016-09-07
00842188100444Foot PlatesSP20-3MSP20-3M2016-09-07
00842188100451Foot PlatesSP20-4SP20-42016-09-07
00842188100468Foot PlatesSP20-6SP20-62016-09-07
00842188100475Foot PlatesTP20-5TP20-52016-09-07
00842188100482Foot PlatesTP20-7TP20-72016-09-07
00842188100888Locking PlatesBRGPBRGP2016-09-07
00842188100949Hook PlatesMHOOK-5MHOOK-52016-09-07
00842188100956Hook PlatesMHOOK-7MHOOK-72016-09-07
00842188101526Osteotomy Compression PlatesUOCPUOCP2016-09-07
00842188101533Osteotomy Compression PlatesUOCP-SUOCP-S2016-09-07
00842188105425FPS Locking Screw 2.0mmCLS2.0-06CLS2.0-062016-09-07
00842188105432FPS Locking Screw 2.0mmCLS2.0-08CLS2.0-082016-09-07
00842188105449FPS Locking Screw 2.0mmCLS2.0-10CLS2.0-102016-09-07
00842188105456FPS Locking Screw 2.0mmCLS2.0-12CLS2.0-122016-09-07
00842188105463FPS Locking Screw 2.0mmCLS2.0-14CLS2.0-142016-09-07
00842188105470FPS Locking Screw 2.0mmCLS2.0-16CLS2.0-162016-09-07
00842188105487FPS Locking Screw 2.0mmCLS2.0-18CLS2.0-182016-09-07

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Primary DI, Brand, Company table
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