Millennium
Hexagonal Handle Osteotome, 6 1/4" x 1mm, curved
4manufacturers in China registered for this device type
39catalogue 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 | Avalign Technologies, Inc., 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 | 2021-11-01 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-6739513 | In distribution | |
| 85-5489-1186-99 | In distribution | |
| 85-5489-1168-99 | In distribution | |
| 0-46460 | In distribution | |
| 1-410320 | In distribution | |
| 85-5489-1213-99 | In distribution | |
| 1-4103191C | In distribution | |
| 85-5489-1210-99 | In distribution | |
| 1-6739522 | In distribution | |
| 1-6739544 | In distribution | |
| 12-461021 | In distribution | |
| 1-6739543 | In distribution | |
| 0-46453 | In distribution | |
| 0-46448 | In distribution | |
| 0-46450 | In distribution | |
| 1-4940 | In distribution | |
| 1-6739522M | In distribution | |
| 1-410321 | In distribution | |
| 0-46459 | In distribution | |
| 85-5489-1206-99 | In distribution | |
| 12-461020 | In distribution | |
| 1-6739523 | In distribution | |
| 1-410319 | In distribution | |
| 85-5489-1225-99 | In distribution | |
| 1-6739512 | In distribution | |
| 0-46457 | In distribution | |
| 1-6739512M | In distribution | |
| 1-6739532 | In distribution | |
| 1-6739542 | In distribution | |
| 1-410323 | In distribution | |
| 1-6739533 | In distribution | |
| 1-4103191S | In distribution | |
| 1-6739534 | In distribution | |
| 0-46454 | In distribution | |
| 0-46458 | In distribution | |
| 0-46449 | In distribution | |
| 12-461025 | In distribution | |
| 63-9204N | In distribution | |
| 85-58002397 | 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.