IdentiTi
IdentiTi PS Porous Ti Distractor Body, 11 X 9 X 25 mm, 10°
5manufacturers in China registered for this device type
110catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | HTE |
| Device type | Elevator |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-19 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Depth 24 to 70 mm; width 9 to 34 mm; height 4 to 12 mm; angle 5 to 10 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CI-10307 | In distribution | |
| CI-10383-07 | In distribution | |
| 168-12-100-10 | In distribution | |
| CI-10584-06 | In distribution | |
| 130-420-08 | In distribution | |
| 130-420-07 | In distribution | |
| 168-12-000-26 | In distribution | |
| 168-12-000-14 | In distribution | |
| 255-10-04267000 | Depth 70 mm | In distribution |
| 168-12-000-12 | In distribution | |
| 130-420-10 | In distribution | |
| 130-420-06 | In distribution | |
| 168-12-100-16 | In distribution | |
| 130-420-11 | In distribution | |
| CI-10383-06 | In distribution | |
| 130-410-12 | In distribution | |
| 168-12-100-14 | In distribution | |
| CI-10505-11092510 | Depth 25 mm | In distribution |
| 255-16-04166000 | Depth 60 mm | In distribution |
| CI-10383-11 | In distribution | |
| 233-04342405 | Width 34 mm | In distribution |
| CI-10529-12 | In distribution | |
| CI-10480-0514 | In distribution | |
| 168-30 | In distribution | |
| 255-16-04226000 | Depth 60 mm | In distribution |
| CI-10383-12 | In distribution | |
| 168-31-20-00 | In distribution | |
| CI-10383-05 | In distribution | |
| CI-10383-14 | In distribution | |
| 255-10-04167000 | Height 4 mm | In distribution |
| 168-12-200-26 | In distribution | |
| 113-44-2200 | In distribution | |
| 168-12-100-26 | In distribution | |
| 255-12-04226000 | Depth 60 mm | In distribution |
| CI-10480-0516 | In distribution | |
| 114-420-0512 | In distribution | |
| CI-10257 | In distribution | |
| CI-10257-120 | In distribution | |
| CI-10525 | In distribution | |
| CI-10383-15 | In distribution | |
| CI-10505-09092510 | Depth 25 mm | In distribution |
| 130-420-09 | In distribution | |
| 168-31-10-00 | In distribution | |
| 130-410-08 | In distribution | |
| CI-10352 | In distribution | |
| CI-10584-14 | In distribution | |
| 168-12-000-16 | In distribution | |
| 255-16-04186000 | Height 4 mm | In distribution |
| 255-10-04147000 | Width 14 mm | In distribution |
| 114-420-0510 | In distribution | |
| CI-10383-04 | In distribution | |
| 168-12-100-22 | In distribution | |
| CI-10584-10 | In distribution | |
| CI-10584-08 | In distribution | |
| 233-04342410 | Angle 10 ° | In distribution |
| 168-12-000-18 | In distribution | |
| CI-10383-09 | In distribution | |
| 255-16-04246000 | Height 4 mm | In distribution |
| 255-12-04186000 | Depth 60 mm | In distribution |
| 255-12-04166000 | Height 4 mm | In distribution |
| 255-16-04146000 | Width 14 mm | In distribution |
| 255-10-04187000 | Width 18 mm | In distribution |
| 130-410-10 | In distribution | |
| 130-410-06 | In distribution | |
| 168-12-200-10 | In distribution | |
| CI-10604 | In distribution | |
| 130-410-14 | In distribution | |
| 168-12-100-12 | In distribution | |
| 168-12-200-12 | In distribution | |
| CI-10383-13 | In distribution | |
| CI-10505-12092510 | Height 12 mm | In distribution |
| 168-12-000-24 | In distribution | |
| CI-10304-25 | In distribution | |
| 255-12-04146000 | Height 4 mm | In distribution |
| CI-10383-08 | In distribution | |
| 233-04342400 | Depth 24 mm | In distribution |
| 114-420-0508 | In distribution | |
| 168-12-100-20 | In distribution | |
| 168-12-000-10 | In distribution | |
| 168-12-100-24 | In distribution | |
| 113-46-2200 | In distribution | |
| 168-12-200-20 | In distribution | |
| 168-12-200-24 | In distribution | |
| 130-420-05 | In distribution | |
| 168-12-100-18 | In distribution | |
| 255-12-04246000 | Depth 60 mm | In distribution |
| CI-10383-16 | In distribution | |
| 255-12-04206000 | Height 4 mm | In distribution |
| 255-16-04266000 | Depth 60 mm | In distribution |
| 255-10-04247000 | Width 24 mm | In distribution |
| CI-10383-10 | In distribution | |
| 168-31-21-02 | In distribution | |
| 168-12-000-20 | In distribution | |
| 130-420-12 | In distribution | |
| 168-12-200-22 | In distribution | |
| CI-10584-12 | In distribution | |
| 255-10-04207000 | Depth 70 mm | In distribution |
| 168-12-200-14 | In distribution | |
| 255-10-04227000 | Width 22 mm | In distribution |
| 168-31-21-01 | In distribution | |
| CI-10505-08092510 | Depth 25 mm | In distribution |
| 168-12-200-16 | In distribution | |
| 168-12-200-18 | In distribution | |
| 114-420-0506 | In distribution | |
| CI-10488 | In distribution | |
| CI-10505-10092510 | Angle 10 ° | In distribution |
| 255-12-04266000 | Height 4 mm | In distribution |
| 255-16-04206000 | Width 20 mm | In distribution |
| CI-10257-110 | In distribution | |
| 168-12-000-22 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Instruments | Life Instrument Corp. | 383 |
| General Instruments | Alphatec Spine, Inc. | 326 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 209 |
| Battalion | Alphatec Spine, Inc. | 152 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 103 |
| Orthomed | Ortho-MED, Inc. | 100 |
| Tecomet | Tecomet, Inc. | 88 |
| Innomed, Inc. | Innomed, Inc. | 85 |
| General Instrument | Alphatec Spine, Inc. | 85 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 71 |
| Elmed | Elmed, Inc. | 67 |
| Elevator | Depuy Spine, Inc. | 56 |
Showing 12 of 246. All products under Elevator
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.