Spinal System
30 catalogue numbers from 131M1208, listed by Biomet Spine, United States, under Osteotome, Manual. 4 manufacturers in China are registered for this product code.
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 | Biomet Spine, United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2018-07-13 |
| Record revised | 2025-01-03 (version 4) |
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 |
|---|---|---|
| 131M1208 | Osteotome Angled 8 mm | In distribution |
| 131M1119 | Osteotome Straight 19 mm | In distribution |
| 131M1110 | Osteotome Straight 10 mm | In distribution |
| 131M1218 | Osteotome Angled 18 mm | In distribution |
| 131M1209 | Osteotome Angled 9 mm | In distribution |
| 131M1117 | Osteotome Straight 17 mm | In distribution |
| 131M1118 | Osteotome Straight 18 mm | In distribution |
| 131M1112 | Osteotome Straight 12 mm | In distribution |
| 131M1210 | Osteotome Angled 10 mm | In distribution |
| 131M1212 | Osteotome Angled 12 mm | In distribution |
| 131M1216 | Osteotome Angled 16 mm | In distribution |
| 131M1106 | Osteotome Straight 6 mm | In distribution |
| 131M1215 | Osteotome Angled 15 mm | In distribution |
| 131M1120 | Osteotome Straight 20 mm | In distribution |
| 131M1207 | Osteotome Angled 7 mm | In distribution |
| 131M1108 | Osteotome Straight 8 mm | In distribution |
| 131M1206 | Osteotome Angled 6 mm | In distribution |
| 131M1219 | Osteotome Angled 19 mm | In distribution |
| 131M1213 | Osteotome Angled 13 mm | In distribution |
| 131M1107 | Osteotome Straight 7 mm | In distribution |
| 131M1116 | Osteotome Straight 16 mm | In distribution |
| 131M1220 | Osteotome Angled 20 mm | In distribution |
| 131M1211 | Osteotome Angled 11 mm | In distribution |
| 131M1109 | Osteotome Straight 9 mm | In distribution |
| 131M1111 | Osteotome Straight 11 mm | In distribution |
| 131M1217 | Osteotome Angled 17 mm | In distribution |
| 131M1115 | Osteotome Straight 15 mm | In distribution |
| 131M1113 | Osteotome Straight 13 mm | In distribution |
| 131M1114 | Osteotome Straight 14 mm | In distribution |
| 131M1214 | Osteotome Angled 14 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.