FDA.reportPublic FDA data

OptimalMTP™

Primary DI
00810136433500
Brand
OptimalMTP™
Company
Forma Medical, Inc.
Model
6102.2614
Catalog number
6102.2614
Device description
Stainless Steel 1.4mm K-wire, 6 in. Long, Calibrated
Published
2026-01-30
Public version status
New
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
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
00810136433500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136433500008101364335008101364335000810136433500

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, single-useA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch
Outer Diameter1.6Millimeter

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
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
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
00810136433166OptimalMTP®1102.31201102.31202025-06-30
00810136433173OptimalMTP®1102.31221102.31222025-06-30
00810136433180OptimalMTP®1102.31241102.31242025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
10886982342508VOLTSynthes GmbHHWC2026-09-25
10886982342515VOLTSynthes GmbHHWC2026-09-25
10886982342522VOLTSynthes GmbHHWC2026-09-25
10886982342539VOLTSynthes GmbHHWC2026-09-25
10886982342546VOLTSynthes GmbHHWC2026-09-25
10886982342553VOLTSynthes GmbHHWC2026-09-25
10886982342560VOLTSynthes GmbHHWC2026-09-25
10886982342577VOLTSynthes GmbHHWC2026-09-25
10886982342584VOLTSynthes GmbHHWC2026-09-25
10886982342591VOLTSynthes GmbHHWC2026-09-25