FDA.reportPublic FDA data

OptimalMTP®

Primary DI
00810136432916
Brand
OptimalMTP®
Company
Forma Medical, Inc.
Model
6100.1105
Catalog number
6100.1105
Device description
Long Distal Trocar, MIS Targeting Instrument, AO Quick Connect
Published
2024-07-28
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810136432916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136432916008101364329168101364329160810136432916

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use 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
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
00810136433166OptimalMTP®1102.31201102.31202025-06-30
00810136433173OptimalMTP®1102.31221102.31222025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
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00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
10886982350732VOLTSynthes GmbHHRS2026-09-25
10886982350749VOLTSynthes GmbHHRS2026-09-25
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10886982350800VOLTSynthes GmbHHRS2026-09-25
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10886982350824VOLTSynthes GmbHHRS2026-09-25
10886982350831VOLTSynthes GmbHHRS2026-09-25
10886982350848VOLTSynthes GmbHHRS2026-09-25
10886982350855VOLTSynthes GmbHHRS2026-09-25
10886982350862VOLTSynthes GmbHHRS2026-09-25
10886982350879VOLTSynthes GmbHHRS2026-09-25