OptimalHT™ 1103.1925
GUDID 00810136430486
1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 25MM LONG
Forma Medical, Inc.
Orthopaedic bone screw (non-sliding)| Primary Device ID | 00810136430486 |
| NIH Device Record Key | 5149eb11-cc41-4745-b59e-a5a18b6a60af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptimalHT™ |
| Version Model Number | 1103.1925 |
| Catalog Number | 1103.1925 |
| Company DUNS | 126585966 |
| Company Name | Forma Medical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Length | 25 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810136430486 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230945
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
[00810136430486]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-28 |
| Device Publish Date | 2023-12-20 |
On-Brand Devices [OptimalHT™]
| 00810136430622 | MIS Targeting Instrument, Radiopaque, 1.1mm Wire, Offset |
| 00810136430615 | OptimalHT 2.0 1.3mm Drill, AO Quick Connect, Solid |
| 00810136430608 | OptimalHT 2.0 T7 Hexalobe, AO Quick Connect, Solid |
| 00810136430592 | OptimalHT 2.0 MIS Targeting Device, Wire-Free |
| 00810136430585 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 42MM LONG |
| 00810136430578 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 40MM LONG |
| 00810136430561 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 38MM LONG |
| 00810136430554 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 36MM LONG |
| 00810136430547 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 35MM LONG |
| 00810136430530 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 34MM LONG |
| 00810136430523 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 32MM LONG |
| 00810136430516 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 30MM LONG |
| 00810136430509 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 28MM LONG |
| 00810136430493 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 26MM LONG |
| 00810136430486 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 25MM LONG |
| 00810136430479 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 24MM LONG |
| 00810136430462 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 22MM LONG |
| 00810136430455 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 20MM LONG |
| 00810136430448 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 18MM LONG |
| 00810136430431 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 16MM LONG |
| 00810136430424 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 15MM LONG |
| 00810136430417 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 14MM LONG |
| 00810136430400 | 1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 12MM LONG |
| 00810136430394 | MIS Targeting Instrument, Handled, 1.4mm Wire, With Elevator |
| 00810136430387 | Cannulated Depth Gauge |
| 50810136430375 | Cobalt Chrome 1.4mm K-wire |
| 50810136430368 | Stainless Steel 1.4mm K-wire |
| 00810136430356 | MIS Targeting Instrument, Handled, 1.1mm Wire, With Elevator |
| 00810136430349 | MIS Targeting Instrument, Radiopaque, 1.1mm Wire, In-line |
| 00810136430332 | MIS Targeting Instrument, Handled, 1.4mm Wire |
| 50810136430184 | Cobalt Chrome 1.1mm K-wire, 4 in. long with depth marking |
| 00810136430011 | MIS Targeting Instrument, Handled, 0.9mm wire |
| 00810136430288 | 2.5mm Headless Compression Screws, Cancellous Head, 40mm long |
| 00810136430271 | 2.5mm Headless Compression Screws, Cancellous Head, 35mm long |
| 00810136430264 | 2.5mm Headless Compression Screws, Cancellous Head, 30mm long |
| 00810136430257 | 2.5mm Headless Compression Screws, Cancellous Head, 25mm long |
| 00810136430240 | 2.5mm Headless Compression Screws, Cancellous Head, 20mm long |
| 00810136430233 | 2.0mm Headless Compression Screws, Cancellous Head, 40mm long |
| 00810136430226 | 2.0mm Headless Compression Screws, Cancellous Head, 35mm long |
| 00810136430219 | 2.0mm Headless Compression Screws, Cancellous Head, 30mm long |
| 00810136430202 | 2.0mm Headless Compression Screws, Cancellous Head, 25mm long |
| 00810136430196 | 2.0mm Headless Compression Screws, Cancellous Head, 20mm long |
| 50810136430177 | Cobalt Chrome 0.9mm K-wire, 4 in. long with depth marking |
| 50810136430160 | Stainless Steel 1.1mm K-wire 4 in. long with depth marking |
| 50810136430153 | Stainless Steel 0.9mm K-wire, 4 in. long with depth marking |
| 00810136430134 | MIS Targeting Instrument, Handled with Elevator, 0.9mm Wire |
| 00810136430127 | Burr, Hammertoe Specific |
| 00810136430110 | 1.9mm Drill, AO Quick Connect, Cannulated |
| 00810136430103 | 1.7mm Drill, AO Quick Connect, Cannulated |
| 00810136430097 | 2.5mm Driver, T8 Hexalobe, AO Quick Connect, Cannulated |
Trademark Results [OptimalHT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 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.