Integra® Miltex®
Integra® Miltex® Swiss Pattern Osteotome Set, Includes: 9 Osteotomes from 2mm to 20mm in Sterilizer Case
4manufacturers in China registered for this device type
131catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-05 |
| Record revised | 2025-02-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Length 7 in; width 2 to 12 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27-270 | In distribution | |
| 62-122 | In distribution | |
| 62-157 | In distribution | |
| 62-124 | In distribution | |
| 27-502 | In distribution | |
| PM-044424 | In distribution | |
| 62-105 | In distribution | |
| 62-144 | In distribution | |
| 62-166 | In distribution | |
| 62-162 | In distribution | |
| PM-044402 | In distribution | |
| 27-274 | In distribution | |
| 62-153 | In distribution | |
| 62-145 | In distribution | |
| PM-4818 | Length 7 in | In distribution |
| MH27-500 | In distribution | |
| 62-163 | In distribution | |
| PM-044406 | In distribution | |
| 27-336 | In distribution | |
| 27-449 | In distribution | |
| PM-1520 | In distribution | |
| 62-141 | In distribution | |
| 62-140 | In distribution | |
| 62-161 | In distribution | |
| 27-272 | In distribution | |
| 62-104 | In distribution | |
| 62-100 | In distribution | |
| 62-158 | In distribution | |
| 27-602A | In distribution | |
| PM-044432 | In distribution | |
| 62-165 | In distribution | |
| 27-333 | In distribution | |
| 62-106 | In distribution | |
| 27-512 | 9mm Wide Blade | In distribution |
| 27-490 | In distribution | |
| MH27-502 | In distribution | |
| 62-101 | In distribution | |
| MH27-506 | In distribution | |
| 27-488 | In distribution | |
| 27-602 | In distribution | |
| PM-044404 | In distribution | |
| MH27-494 | In distribution | |
| 27-440 | In distribution | |
| 27-518 | 7-3/4″ | In distribution |
| 27-522 | 7-3/4″ | In distribution |
| PM-044408 | In distribution | |
| 27-542 | 7-3/4″ | In distribution |
| MH27-496 | In distribution | |
| 27-599 | In distribution | |
| 62-168 | In distribution | |
| 27-335 | In distribution | |
| MH27-498 | In distribution | |
| MH27-492 | In distribution | |
| 27-532 | 7-3/4″ | In distribution |
| 27-446 | In distribution | |
| PM-711 | In distribution | |
| PM-4820 | Length 7 in | In distribution |
| 27-603 | In distribution | |
| 62-169 | In distribution | |
| 27-538 | 7-3/4″ | In distribution |
| 27-331 | In distribution | |
| 62-155 | In distribution | |
| 27-450 | In distribution | |
| 27-508 | In distribution | |
| MH27-499 | In distribution | |
| 27-499 | In distribution | |
| 27-498 | In distribution | |
| 62-121 | In distribution | |
| 27-492 | In distribution | |
| 27-605 | In distribution | |
| MH27-490 | In distribution | |
| 27-600 | In distribution | |
| PM-044410 | In distribution | |
| 27-506 | In distribution | |
| PM-044430 | In distribution | |
| 62-102 | In distribution | |
| PM-4812 | Length 7 in | In distribution |
| PM-044412 | In distribution | |
| 27-520 | 7-3/4″ | In distribution |
| 27-440C | In distribution | |
| 62-167 | In distribution | |
| 27-536 | 7-3/4″ | In distribution |
| 62-123 | In distribution | |
| 27-494 | In distribution | |
| MH27-508 | In distribution | |
| 62-103 | In distribution | |
| 27-447 | In distribution | |
| 62-156 | In distribution | |
| 62-152 | In distribution | |
| PM-4811 | Length 7 in | In distribution |
| 27-442C | In distribution | |
| 62-159 | In distribution | |
| 27-540 | 7-3/4″ | In distribution |
| 27-334 | In distribution | |
| 62-154 | In distribution | |
| 27-450C | In distribution | |
| PM-4810 | Length 7 in | In distribution |
| 27-534 | 7-3/4″ | In distribution |
| 62-146 | In distribution | |
| MH27-504 | In distribution | |
| 27-504 | In distribution | |
| 27-438 | In distribution | |
| 27-332 | In distribution | |
| 27-496 | In distribution | |
| 27-510 | 7-3/4″ | In distribution |
| 27-601 | In distribution | |
| 27-446C | In distribution | |
| 27-444 | In distribution | |
| 27-610 | In distribution | |
| 27-444C | In distribution | |
| 27-438C | In distribution | |
| 27-448C | In distribution | |
| MH27-488 | In distribution | |
| 27-516 | 16mm Wide Blade | In distribution |
| 27-442 | In distribution | |
| 27-530 | 7-3/4″ | In distribution |
| PM-4815 | Length 7 in | In distribution |
| 27-500 | In distribution | |
| PM-044422 | In distribution | |
| 62-125 | In distribution | |
| 27-452C | In distribution | |
| 62-160 | In distribution | |
| 27-604 | In distribution | |
| 27-448 | In distribution | |
| PM-044428 | In distribution | |
| 62-147 | In distribution | |
| 27-514 | 7-3/4″ | In distribution |
| PM-044426 | In distribution | |
| 27-601A | In distribution | |
| 62-149 | In distribution | |
| 27-452 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 155 |
| 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 |
| 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.