Boss Instruments
Boss Spinal Fusion Osteotome, full curve, 8mm, 9 1/2"
4manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1), Guangdong (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 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Boss Instruments, Ltd., United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
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 |
|---|---|---|
| 70-4010 | In distribution | |
| 570-3821 | In distribution | |
| 70-3962 | In distribution | |
| 570-3801 | In distribution | |
| 70-3948 | In distribution | |
| 70-3965 | In distribution | |
| 570-3820 | In distribution | |
| 70-3952 | In distribution | |
| 70-3958 | In distribution | |
| 70-3954 | In distribution | |
| 21-0222 | In distribution | |
| 21-0226 | In distribution | |
| 70-3950 | In distribution | |
| 21-0200 | In distribution | |
| 70-3960 | In distribution | |
| 70-3946 | In distribution | |
| 70-3947 | In distribution | |
| 70-3956 | In distribution | |
| 570-3800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 155 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 131 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 121 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 110 |
| Osteotomy Instruments | Alphatec Spine, Inc. | 109 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 97 |
| Tecomet | Tecomet, Inc. | 76 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 75 |
| Orthomed | Ortho-MED, Inc. | 73 |
| Hayden Medical | Hayden Medical Inc | 70 |
| Ambler Surgical | Ambler Surgical, LLC | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 66 |
Showing 12 of 333. All products under Osteotome, Manual
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.