Disc Preparation Instruments
Osteotome Straight 16 mm
4manufacturers in China registered for this device type
30catalogue 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 | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-11-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 131M1116 | Device Size Text, specify—Osteotome Straight 16 mm | In distribution |
| 131M1208 | Device Size Text, specify—Osteotome Angled 8 mm | In distribution |
| 131M1108 | Device Size Text, specify—Osteotome Straight 8 mm | In distribution |
| 131M1120 | Device Size Text, specify—Osteotome Straight 20 mm | In distribution |
| 131M1212 | Device Size Text, specify—Osteotome Angled 12 mm | In distribution |
| 131M1216 | Device Size Text, specify—Osteotome Angled 16 mm | In distribution |
| 131M1209 | Device Size Text, specify—Osteotome Angled 9 mm | In distribution |
| 131M1219 | Device Size Text, specify—Osteotome Angled 19 mm | In distribution |
| 131M1107 | Device Size Text, specify—Osteotome Straight 7 mm | In distribution |
| 131M1213 | Device Size Text, specify—Osteotome Angled 13 mm | In distribution |
| 131M1214 | Device Size Text, specify—Osteotome Angled 14 mm | In distribution |
| 131M1220 | Device Size Text, specify—Osteotome Angled 20 mm | In distribution |
| 131M1118 | Device Size Text, specify—Osteotome Straight 18 mm | In distribution |
| 131M1110 | Device Size Text, specify—Osteotome Straight 10 mm | In distribution |
| 131M1109 | Device Size Text, specify—Osteotome Straight 9 mm | In distribution |
| 131M1115 | Device Size Text, specify—Osteotome Straight 15 mm | In distribution |
| 131M1210 | Device Size Text, specify—Osteotome Angled 10 mm | In distribution |
| 131M1114 | Device Size Text, specify—Osteotome Straight 14 mm | In distribution |
| 131M1218 | Device Size Text, specify—Osteotome Angled 18 mm | In distribution |
| 131M1217 | Device Size Text, specify—Osteotome Angled 17 mm | In distribution |
| 131M1211 | Device Size Text, specify—Osteotome Angled 11 mm | In distribution |
| 131M1113 | Device Size Text, specify—Osteotome Straight 13 mm | In distribution |
| 131M1111 | Device Size Text, specify—Osteotome Straight 11 mm | In distribution |
| 131M1112 | Device Size Text, specify—Osteotome Straight 12 mm | In distribution |
| 131M1215 | Device Size Text, specify—Osteotome Angled 15 mm | In distribution |
| 131M1206 | Device Size Text, specify—Osteotome Angled 6 mm | In distribution |
| 131M1117 | Device Size Text, specify—Osteotome Straight 17 mm | In distribution |
| 131M1106 | Device Size Text, specify—Osteotome Straight 6 mm | In distribution |
| 131M1207 | Device Size Text, specify—Osteotome Angled 7 mm | In distribution |
| 131M1119 | Device Size Text, specify—Osteotome Straight 19 mm | 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.