Precice®
GUDID 00887517028624
4.0mm x 42.5mm Screw, Fully Threaded
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis distraction rod Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction Arthrodesis nail, distraction| Primary Device ID | 00887517028624 |
| NIH Device Record Key | 19f66b14-a189-417a-a485-7a68c1c34d83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precice® |
| Version Model Number | SFT4-425-S |
| Company DUNS | 837845234 |
| Company Name | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887517028624 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200430
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-23 |
| Device Publish Date | 2021-06-15 |
On-Brand Devices [Precice® ]
| 00887517055507 | REMOVAL TRAY ASSEMBLY |
| 00887517054302 | MODULAR REAMER-OSTEOTOME TRAY ASSEMBLY |
| 00887517030801 | Ankle Salvage Instrument Tray |
| 00887517022271 | Precice Hinterman, Ankle Salvage, Sm |
| 00887517022264 | 8.0mm to 13.0 Tapered Reamer |
| 00887517022257 | 8.0mm to 12.0 Tapered Reamer |
| 00887517022240 | 8.0mm to 11.0 Tapered Reamer |
| 00887517022233 | Precice Hex Driver, 3.5mm Short Solid |
| 00887517022226 | Precice Drill Sleeve, Ankle Salvage |
| 00887517022219 | Precice Guide Tube, Ankle Salvage |
| 00887517021090 | 3.5mm, Locking Hexdriver, Short |
| 00887517021083 | Drill Sleeve |
| 00887517021076 | Extractor - Ankle Salvage |
| 00887517021069 | Guide Tube |
| 00887517021052 | PRECICE Hinterman, Ankle Salvage, Lg |
| 00887517021045 | Insertion Handle - Ankle Salvage |
| 00887517021038 | Locking Bolt - Ankle Salvage |
| 00887517021021 | Locking Nut - Ankle Salvage |
| 00887517021014 | P-A Quick Connect |
| 00887517021007 | Perfect Circle Targeter |
| 00887517020994 | Radiographic Ruler |
| 00887517020987 | Straight Awl |
| 00887517020970 | PRECICE Hex Driver, 3.5mm Long Solid |
| 00887517020963 | Screw Depth Gauge - Dipstick |
| 00887517020956 | Screw Depth Gauge |
| 00887517020949 | PRECICE 3.5mm Set Screw Driver |
| 00887517020932 | Self-Retaining Screwdriver, 3.5mm, Long |
| 00887517020925 | Self-Retaining Screwdriver, 3.5mm, Short |
| 00887517020918 | Soft Tissue Protector Tube |
| 00887517020901 | Trocar, 6.0mm |
| 00887517017994 | Targeting Handle - Ankle Salvage |
| 00195377039927 | 3.2mm x 125mm Steinmann Pin, trocar tip |
| 00195377024374 | PRECICE Drill Bit, 3.5mm Full Thrd Ankle |
| 00195377024367 | PRECICE Drill Bit, 4.0mm Full Thrd Ankle |
| 00195377024350 | PRECICE Drill Bit, 4.3mm Full Thrd Ankle |
| 00195377024336 | PRECICE Starter Drill Bit, Ankle |
| 00195377024251 | PRECICE Step Drill Bit, 4.0mm Ankle |
| 00195377024244 | PRECICE Step Drill Bit, 4.5mm Ankle |
| 00195377024237 | PRECICE Step Drill Bit, 5.0mm Ankle |
| 00195377024220 | PRECICE Step Drill Bit, 6.0mm Ankle |
| 00887517028723 | 4.0mm x 100mm Screw, Fully Threaded |
| 00887517028716 | 4.0mm x 20mm Screw, Fully Threaded |
| 00887517028709 | 4.0mm x 22.5mm Screw, Fully Threaded |
| 00887517028693 | 4.0mm x 25mm Screw, Fully Threaded |
| 00887517028686 | 4.0mm x 27.5mm Screw, Fully Threaded |
| 00887517028679 | 4.0mm x 30mm Screw, Fully Threaded |
| 00887517028662 | 4.0mm x 32.5mm Screw, Fully Threaded |
| 00887517028655 | 4.0mm x 35mm Screw, Fully Threaded |
| 00887517028648 | 4.0mm x 37.5mm Screw, Fully Threaded |
| 00887517028631 | 4.0mm x 40mm Screw, Fully Threaded |
Trademark Results [Precice]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRECICE 97287304 not registered Live/Pending |
PRECICE MOTORSPORTS LLC 2022-02-28 |
 PRECICE 88073801 not registered Live/Pending |
Epic Ice, LLC 2018-08-10 |
 PRECICE 85064864 4158334 Live/Registered |
NUVASIVE, INC. 2010-06-16 |
 PRECICE 76250632 not registered Dead/Abandoned |
KLA-Tencor Corporation 2001-05-03 |
 PRECICE 75092861 not registered Dead/Abandoned |
Cadence Design Systems, Inc. 1996-04-23 |
 PRECICE 75072688 not registered Dead/Abandoned |
BIODEX MEDICAL SYSTEMS, INC. 1996-03-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.