FDA.reportPublic FDA data

OptimalMTP®

Primary DI
00810136433432
Brand
OptimalMTP®
Company
Forma Medical, Inc.
Model
6102.4009
Catalog number
6102.4009
Device description
CANNULATED T9 HEXALOBE DRIVER
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K230945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230945000Forma Medical Headless Compression ScrewForma Medical, Inc.2023-07-18HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810136433432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136433432008101364334328101364334320810136433432

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
0000000000support@formamedical.com

Regulatory Flags#

DUNS number
126585966
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
00810136433593OptimalMTP®1102.1306.191102.1306.192026-10-16
00810136433609OptimalMTP®1102.2306.191102.2306.192026-10-16
00810136433500OptimalMTP™6102.26146102.26142026-01-30
00810136433517OptimalMTP™6102.28146102.28142026-01-30
00810136433524OptimalMTP™6102.28166102.28162026-01-30
00810136433548OptimalMTP™6102.29146102.29142026-01-30
00810136433555OptimalMTP™6102.29166102.29162026-01-30
00810136433562OptimalMTP™6102.29186102.29182026-01-30
00810136433456OptimalTMT™1102.1304.171102.1304.172025-06-30
00810136433463OptimalTMT™1102.2304.171102.2304.172025-06-30
00810136432961OptimalMTP®1102.1305.161102.1305.162025-01-25
00810136432978OptimalMTP®1102.2305.161102.2305.162025-01-25
00810136433104OptimalMTP®1102.1304.151102.1304.152025-01-25
00810136433111OptimalMTP®1102.2304.151102.2304.152025-01-25
00810136431049OptimalMTP®1102.1304.011102.1304.012024-07-24
00810136431056OptimalMTP®1102.2304.011102.2304.012024-07-24
00810136431063OptimalMTP®1102.1304.021102.1304.022024-07-24
00810136431070OptimalMTP®1102.2304.021102.2304.022024-07-24
00810136431087OptimalMTP®1102.1305.031102.1305.032024-07-24
00810136431094OptimalMTP®1102.2305.031102.2305.032024-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112599244TriLEAPSynthes GmbHHWC2025-03-17
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