FDA.reportPublic FDA data

OptimalMTP™

Primary DI
00810136433555
Brand
OptimalMTP™
Company
Forma Medical, Inc.
Model
6102.2916
Catalog number
6102.2916
Device description
TowerTack, 2x16mm
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810136433555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136433555008101364335558101364335550810136433555

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16Millimeter
Outer Diameter2Millimeter

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
00810136433500OptimalMTP™6102.26146102.26142026-01-30
00810136433517OptimalMTP™6102.28146102.28142026-01-30
00810136433524OptimalMTP™6102.28166102.28162026-01-30
00810136433548OptimalMTP™6102.29146102.29142026-01-30
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
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586713CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586720CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586737CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10