Orthomed
Army Pattern Osteotome 6 1/2" 18MM
4manufacturers in China registered for this device type
73catalogue 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 | Ortho-MED, Inc., United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-08-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM 46-0268 | In distribution | |
| OM 46-0353 | In distribution | |
| OM 46-0288 | In distribution | |
| OM 46-0328 | In distribution | |
| OM 46-0352 | In distribution | |
| OM 46-0379 | In distribution | |
| OM 46-0335 | In distribution | |
| OM 46-0373 | In distribution | |
| OM 46-0322 | In distribution | |
| OM 46-0332 | In distribution | |
| OM 46-0278 | In distribution | |
| OM 46-0359 | In distribution | |
| OM 46-0345 | In distribution | |
| OM 46-0350 | In distribution | |
| OM 46-0356C | In distribution | |
| OM 46-0286 | In distribution | |
| OM 46-0378 | In distribution | |
| OM 46-0340 | In distribution | |
| OM 46-0306 | In distribution | |
| OM 46-0274 | In distribution | |
| OM 46-0355 | In distribution | |
| OM 46-0346 | In distribution | |
| OM 46-0304 | In distribution | |
| OM 46-0353C | In distribution | |
| OM 46-0336 | In distribution | |
| OM 46-0270 | In distribution | |
| OM 46-0342 | In distribution | |
| OM 46-0350C | In distribution | |
| OM 46-0380 | In distribution | |
| OM 46-0384 | In distribution | |
| OM 46-0349 | In distribution | |
| OM 46-0381 | In distribution | |
| OM 46-0358C | In distribution | |
| OM 46-0284 | In distribution | |
| OM 46-0365 | In distribution | |
| OM 46-0330 | In distribution | |
| OM 46-0368 | In distribution | |
| OM 46-0280 | In distribution | |
| OM 46-0348 | In distribution | |
| OM 46-0362 | In distribution | |
| OM 46-0272 | In distribution | |
| OM 46-0352C | In distribution | |
| OM 46-0367 | In distribution | |
| OM 46-0377 | In distribution | |
| OM 46-0358 | In distribution | |
| OM 46-0366 | In distribution | |
| OM 46-0310 | In distribution | |
| OM 46-0361 | In distribution | |
| OM 46-0354C | In distribution | |
| OM 46-0364 | In distribution | |
| OM 46-0376 | In distribution | |
| OM 46-0347 | In distribution | |
| OM 46-0383 | In distribution | |
| OM 46-0344 | In distribution | |
| OM 46-0337 | In distribution | |
| OM 46-0343 | In distribution | |
| OM 46-0351 | In distribution | |
| OM 46-0314 | In distribution | |
| OM 46-0356 | In distribution | |
| OM 46-0348C | In distribution | |
| OM 46-0355C | In distribution | |
| OM 46-0333 | In distribution | |
| OM 46-0363 | In distribution | |
| OM 46-0351C | In distribution | |
| OM 46-0331 | In distribution | |
| OM 46-0338 | In distribution | |
| OM 46-0318 | In distribution | |
| OM 46-0354 | In distribution | |
| OM 46-0329 | In distribution | |
| OM 46-0360 | In distribution | |
| OM 46-0349C | In distribution | |
| OM 46-0276 | In distribution | |
| OM 46-0382 | 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 |
| Hayden Medical | Hayden Medical Inc | 70 |
| Ambler Surgical | Ambler Surgical, LLC | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 66 |
| Osteotome, Manual | George Tiemann & Co. | 64 |
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.