Integrate-C
Rasping Trial - Medium footprint 10deg, 11/12 height
1manufacturer
124catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Happe Spine, United States |
|---|---|
| FDA product code | LYQ |
| Device type | Accessories, Fixation, Spinal Intervertebral Body |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K222004 |
| Record published | 2023-08-24 |
| Record revised | 2023-12-18 (version 2) |
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, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Trial – Large 20 x 15 x 7/8 mm, 7 deg | In distribution | |
| Trial-Small 15x12x6mm 7deg | In distribution | |
| Rasp | In distribution | |
| Trial – Large 20 x 15 x 5/6 mm, 10 deg | In distribution | |
| Trial – Medium 17 x 14 x 9/10 mm, 10 deg | In distribution | |
| Trial – Large 20 x 15 x 5/6 mm, 7 deg | In distribution | |
| Trial-Medium 17x14x13mm 7deg | In distribution | |
| Trial-Medium 17x14x11mm 7deg | In distribution | |
| Trial-Small 15x12x8mm 10deg | In distribution | |
| Trial-Medium 17x14x14mm 10deg | In distribution | |
| Trial-Large 20x15x11mm 10deg | In distribution | |
| Trial-Medium 17x14x7mm 10deg | In distribution | |
| Removal Tool | In distribution | |
| Rasping Trial – Medium 17 x 14 x 7/8 mm, 7 deg | In distribution | |
| Trial-Large 20x15x6mm 7deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 5/6 mm, 7 deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 11/12 mm, 10 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 13/14mm , 10 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 11/12 mm, 10 deg | In distribution | |
| Trial-Medium 17x14x9mm 7deg | In distribution | |
| Trial-Large 20x15x12mm 10deg | In distribution | |
| Trial – Small 15 x 12 x 7/8 mm, 7 deg | In distribution | |
| Trial-Large 20x15x6mm 10deg | In distribution | |
| Trial-Medium 17x14x8mm 10deg | In distribution | |
| Trial-Small 15x12x7mm 10deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 11/12 mm, 7 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 7/8 mm, 10 deg | In distribution | |
| Trial-Small 15x12x12mm 10deg | In distribution | |
| Trial – Small 15 x 12 x 13/14mm , 7 deg | In distribution | |
| Trial-Small 15x12x9mm 10deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 5/6 mm, 10 deg | In distribution | |
| Trial-Small 15x12x12mm 7deg | In distribution | |
| Inserter Handle | In distribution | |
| Trial-Large 20x15x12mm 7deg | In distribution | |
| Trial-Large 20x15x14mm 10deg | In distribution | |
| Trial – Small 15 x 12 x 5/6 mm, 10 deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 9/10 mm, 7 deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 13/14mm , 7 deg | In distribution | |
| Trial-Large 20x15x10mm 10deg | In distribution | |
| Trial-Large 20x15x8mm 7deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 9/10 mm, 10 deg | In distribution | |
| Trial-Small 15x12x10mm 10deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 7/8 mm, 7 deg | In distribution | |
| Trial – Small 15 x 12 x 9/10 mm, 10 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 13/14mm , 7 deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 9/10 mm, 7 deg | In distribution | |
| Trial-Large 20x15x7mm 10deg | In distribution | |
| Trial-Medium 17x14x7mm 7deg | In distribution | |
| Trial-Small 15x12x14mm 10deg | In distribution | |
| Trial-Large 20x15x9mm 10deg | In distribution | |
| Trial-Small 15x12x10mm 7deg | In distribution | |
| Trial-Small 15x12x13mm 10deg | In distribution | |
| Trial-Small 15x12x8mm 7deg | In distribution | |
| Trial-Large 20x15x8mm 10deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 11/12 mm, 7 deg | In distribution | |
| Trial – Small 15 x 12 x 11/12 mm, 10 deg | In distribution | |
| Trial-Medium 17x14x9mm 10deg | In distribution | |
| Trial-Large 20x15x5mm 10deg | In distribution | |
| Trial – Small 15 x 12 x 7/8 mm, 10 deg | In distribution | |
| Trial-Large 20x15x10mm 7deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 9/10 mm, 10 deg | In distribution | |
| Trial – Large 20 x 15 x 9/10 mm, 7 deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 13/14mm , 10 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 9/10 mm, 7 deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 11/12 mm, 10 deg | In distribution | |
| Trial-Medium 17x14x6mm 7deg | In distribution | |
| Trial – Small 15 x 12 x 11/12 mm, 7 deg | In distribution | |
| Trial-Small 15x12x5mm 10deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 13/14mm , 10 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 5/6 mm, 7 deg | In distribution | |
| Trial – Medium 17 x 14 x 9/10 mm, 7 deg | In distribution | |
| Trial – Large 20 x 15 x 9/10 mm, 10 deg | In distribution | |
| Trial-Medium 17x14x10mm 10deg | In distribution | |
| Trial-Medium 17x14x10mm 7deg | In distribution | |
| Trial – Small 15 x 12 x 5/6 mm, 7 deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 13/14mm , 7 deg | In distribution | |
| Trial – Large 20 x 15 x 7/8 mm, 10 deg | In distribution | |
| Trial – Large 20 x 15 x 13/14mm , 10 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 11/12 mm, 7 deg | In distribution | |
| Trial-Large 20x15x13mm 10deg | In distribution | |
| Trial-Small 15x12x13mm 7deg | In distribution | |
| Trial – Medium 17 x 14 x 7/8 mm, 10 deg | In distribution | |
| Trial-Large 20x15x14mm 7deg | In distribution | |
| Trial – Large 20 x 15 x 11/12 mm, 7 deg | In distribution | |
| Trial-Large 20x15x13mm 7deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 7/8 mm, 7 deg | In distribution | |
| Trial-Small 15x12x9mm 7deg | In distribution | |
| Trial-Medium 17x14x14mm 7deg | In distribution | |
| Trial-Large 20x15x5mm 7deg | In distribution | |
| Trial-Small 15x12x6mm 10deg | In distribution | |
| Trial-Medium 17x14x11mm 10deg | In distribution | |
| Trial-Medium 17x14x5mm 10deg | In distribution | |
| Trial – Medium 17 x 14 x 13/14mm , 7 deg | In distribution | |
| Trial – Small 15 x 12 x 9/10 mm, 7 deg | In distribution | |
| Trial – Medium 17 x 14 x 5/6 mm, 7 deg | In distribution | |
| Rasping Trial – Large 20 x 15 x 9/10 mm, 10 deg | In distribution | |
| Trial – Medium 17 x 14 x 11/12 mm, 10 deg | In distribution | |
| Trial – Medium 17 x 14 x 11/12 mm, 7 deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 7/8 mm, 10 deg | In distribution | |
| Trial-Small 15x12x14mm 7deg | In distribution | |
| Trial-Small 15x12x7mm 7deg | In distribution | |
| Trial – Medium 17 x 14 x 13/14mm , 10 deg | In distribution | |
| Trial-Medium 17x14x12mm 10deg | In distribution | |
| Trial-Medium 17x14x6mm 10deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 5/6 mm, 7 deg | In distribution | |
| Trial-Medium 17x14x5mm 7deg | In distribution | |
| Trial-Medium 17x14x13mm 10deg | In distribution | |
| Trial – Large 20 x 15 x 13/14mm , 7 deg | In distribution | |
| Rasping Trial – Small 15 x 12 x 5/6 mm, 10 deg | In distribution | |
| Trial-Small 15x12x5mm, 7deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 7/8 mm, 10 deg | In distribution | |
| Trial – Large 20 x 15 x 11/12 mm, 10 deg | In distribution | |
| Trial-Small 15x12x11mm 7deg | In distribution | |
| Trial-Large 20x15x11mm 7deg | In distribution | |
| Trial – Small 15 x 12 x 13/14mm , 10 deg | In distribution | |
| Trial-Small 15x12x11mm 10deg | In distribution | |
| Trial-Medium 17x14x8mm 7deg | In distribution | |
| Trial-Large 20x15x9mm 7deg | In distribution | |
| Inserter Threaded Shaft | In distribution | |
| Trial-Medium 17x14x12mm 7deg | In distribution | |
| Trial-Large 20x15x7mm 7deg | In distribution | |
| Trial – Medium 17 x 14 x 5/6 mm, 10 deg | In distribution | |
| Trial – Medium 17 x 14 x 7/8 mm, 7 deg | In distribution | |
| Rasping Trial – Medium 17 x 14 x 5/6 mm, 10 deg | In distribution |
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|---|---|---|
| SureMAX-SA | Additive Implants | 34 |
| SureMAX | Additive Implants | 16 |
| PTS | PT Solutions, LLC | 12 |
| Riva Posterior Fixation System | Xenix Medical | 8 |
| KeyLift™ | Flospine LLC | 6 |
| Riva Pedicle Screw System | Xenix Medical | 6 |
| Coda™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 3 |
| Distraction Screw, 12MM Pouch | Medline Industries, Inc. | 2 |
| Distraction Screw, 14MM pouch | Medline Industries, Inc. | 2 |
| LUX Expandable Interbody System | Xenix Medical | 2 |
| Distraction Pin, 12MM Pouch | Medline Industries, Inc. | 2 |
| ABS Med Distraction Pin | Medline Industries, Inc. | 2 |
Showing 12 of 22. All products under Accessories, Fixation, Spinal Intervertebral Body
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.