H-Graft Interspinous Allograft
Catalogue number X078-0025, listed by Xtant Medical Holdings, Inc., United States, under Mallet. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | HXL |
| Device type | Mallet |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-08-28 |
| Record revised | 2022-06-10 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X078-0025 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 115 |
| Surgical Direct | Surgical Direct, Inc. | 77 |
| Aesculap | Aesculap AG | 24 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 20 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 18 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 17 |
| Tecomet | Tecomet, Inc. | 15 |
| Princeton | Princeton Medical Group, Inc. | 14 |
| Hayden Medical | Hayden Medical Inc | 12 |
| General Instruments | Alphatec Spine, Inc. | 11 |
| Sontec Mallet | Sontec Instruments, Inc. | 9 |
| Mallet | Zimmer, Inc. | 8 |
Showing 12 of 132. All products under Mallet
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.