Ambler Surgical
Obwegeser osteotome, 7 1/4'', straight, U-shaped cutting edge, 2 buttons on the tips, round handle
4manufacturers in China registered for this device type
67catalogue 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 | Ambler Surgical, LLC, 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 | 2021-01-04 |
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 |
|---|---|---|
| Jayes osteotome | In distribution | |
| Obwegeser osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Jayes osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| U.S. Army pattern osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| Jayes osteotome | In distribution | |
| Matthew osteotome | In distribution | |
| Stille-Type osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| French-Gillies osteotome | In distribution | |
| Stille-Type osteotome | In distribution | |
| French-Gillies osteotome | In distribution | |
| Jayes osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Stille-Type osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| U.S. Army pattern osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Stille-Type osteotome | In distribution | |
| U.S. Army pattern osteotome | In distribution | |
| Jayes osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| French-Gillies osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| Jayes osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Cement osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| French-Gillies osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| Stille-Type osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Spinal fusion osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Ambler osteotome | In distribution | |
| French-Gillies osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Stille-Type osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Smith-Peterson osteotome | In distribution | |
| Lexer-Mini osteotome | In distribution | |
| Jayes osteotome | 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 |
| 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.