OptimalHT™ 6100.1004

GUDID 00810136430134

MIS Targeting Instrument, Handled with Elevator, 0.9mm Wire

Forma Medical, Inc.

Orthopaedic prosthesis implantation positioning instrument, single-use
Primary Device ID00810136430134
NIH Device Record Key478695ee-8312-4b3a-b434-6726eb3a4dae
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimalHT™
Version Model Number6100.1004
Catalog Number6100.1004
Company DUNS126585966
Company NameForma Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com
Phone0000000000
Emailsupport@formamedical.com

Device Dimensions

Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter
Outer Diameter0.9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810136430134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

[00810136430134]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-01
Device Publish Date2023-12-22

On-Brand Devices [OptimalHT™]

00810136430622MIS Targeting Instrument, Radiopaque, 1.1mm Wire, Offset
00810136430615OptimalHT 2.0 1.3mm Drill, AO Quick Connect, Solid
00810136430608OptimalHT 2.0 T7 Hexalobe, AO Quick Connect, Solid
00810136430592OptimalHT 2.0 MIS Targeting Device, Wire-Free
008101364305851.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 42MM LONG
008101364305781.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 40MM LONG
008101364305611.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 38MM LONG
008101364305541.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 36MM LONG
008101364305471.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 35MM LONG
008101364305301.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 34MM LONG
008101364305231.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 32MM LONG
008101364305161.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 30MM LONG
008101364305091.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 28MM LONG
008101364304931.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 26MM LONG
008101364304861.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 25MM LONG
008101364304791.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 24MM LONG
008101364304621.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 22MM LONG
008101364304551.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 20MM LONG
008101364304481.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 18MM LONG
008101364304311.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 16MM LONG
008101364304241.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 15MM LONG
008101364304171.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 14MM LONG
008101364304001.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 12MM LONG
00810136430394MIS Targeting Instrument, Handled, 1.4mm Wire, With Elevator
00810136430387Cannulated Depth Gauge
50810136430375Cobalt Chrome 1.4mm K-wire
50810136430368Stainless Steel 1.4mm K-wire
00810136430356MIS Targeting Instrument, Handled, 1.1mm Wire, With Elevator
00810136430349MIS Targeting Instrument, Radiopaque, 1.1mm Wire, In-line
00810136430332MIS Targeting Instrument, Handled, 1.4mm Wire
50810136430184Cobalt Chrome 1.1mm K-wire, 4 in. long with depth marking
00810136430011MIS Targeting Instrument, Handled, 0.9mm wire
008101364302882.5mm Headless Compression Screws, Cancellous Head, 40mm long
008101364302712.5mm Headless Compression Screws, Cancellous Head, 35mm long
008101364302642.5mm Headless Compression Screws, Cancellous Head, 30mm long
008101364302572.5mm Headless Compression Screws, Cancellous Head, 25mm long
008101364302402.5mm Headless Compression Screws, Cancellous Head, 20mm long
008101364302332.0mm Headless Compression Screws, Cancellous Head, 40mm long
008101364302262.0mm Headless Compression Screws, Cancellous Head, 35mm long
008101364302192.0mm Headless Compression Screws, Cancellous Head, 30mm long
008101364302022.0mm Headless Compression Screws, Cancellous Head, 25mm long
008101364301962.0mm Headless Compression Screws, Cancellous Head, 20mm long
50810136430177Cobalt Chrome 0.9mm K-wire, 4 in. long with depth marking
50810136430160Stainless Steel 1.1mm K-wire 4 in. long with depth marking
50810136430153Stainless Steel 0.9mm K-wire, 4 in. long with depth marking
00810136430134MIS Targeting Instrument, Handled with Elevator, 0.9mm Wire
00810136430127Burr, Hammertoe Specific
008101364301101.9mm Drill, AO Quick Connect, Cannulated
008101364301031.7mm Drill, AO Quick Connect, Cannulated
008101364300972.5mm Driver, T8 Hexalobe, AO Quick Connect, Cannulated

Trademark Results [OptimalHT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIMALHT
OPTIMALHT
98097309 not registered Live/Pending
Forma Medical, Inc.
2023-07-22
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.