FDA.reportPublic FDA data

OptimalMTP®

Primary DI
00810136432961
Brand
OptimalMTP®
Company
Forma Medical, Inc.
Model
1102.1305.16
Catalog number
1102.1305.16
Device description
Titanium Standard MTP Plate, Left, 5 hole
Published
2025-01-25
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
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
00810136432961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136432961008101364329618101364329610810136432961

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

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
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
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
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140692ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140708ARTEMIS FUZEVILEX LLCHWC2026-07-22