FDA.reportPublic FDA data

CannCompScrew 7.3mm (SelfDrill)

Primary DI
00842188122972
Brand
CannCompScrew 7.3mm (SelfDrill)
Company
Trimed, INC.
Model
S7342
Catalog number
S7342
Device description
Self-Drill CCScrew SThd 7.3, 60mm
Published
2021-01-11
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
K093676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093676000OMNITECH LARGE, TRIMED COMPRESSION SCREWTriMed, Inc.2010-03-17HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188122972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188122972008421881229728421881229720842188122972

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
DM exempt
true
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
00842188131615CannCompScrew 5.5 (Ti)L5546 TL5546 T2026-09-25
00842188131639CannCompScrew 5.5 (Ti)L5550 TL5550 T2026-09-25
00842188131653CannCompScrew 5.5 (Ti)L5554 TL5554 T2026-09-25
00842188131677CannCompScrew 5.5 (Ti)L5558 TL5558 T2026-09-25
00842188131721CannCompScrew 5.5 (Ti)L5570 TL5570 T2026-09-25
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

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