Osteotome
Minimally Invasive, Septum, OS2, Straight, Single Guarded, 4 MM TIP
9manufacturers in China registered for this device type
262catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (2), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | HWM |
| Device type | Osteotome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-23 |
| Record revised | 2024-08-26 (version 5) |
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 |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 38-785-23-04 | 23 CM | In distribution |
| 48-270-03-07 | 16 CM | In distribution |
| 00-102-12-07 | 15 CM | In distribution |
| 23-155-16-07 | 20.5 CM | In distribution |
| 38-883-11-07 | 19 CM | In distribution |
| 995-3994-05 | 19 CM | In distribution |
| 23-124-15-07 | 20 CM | In distribution |
| 995-5238-01 | 15 CM | In distribution |
| 48-167-11-07 | 21 CM | In distribution |
| 23-173-19-07 | 24 CM | In distribution |
| 23-154-16-07 | 20 CM | In distribution |
| 23-154-13-07 | 20 CM | In distribution |
| 48-271-05-07 | 16 CM | In distribution |
| 37-626-08-07 | 15 CM | In distribution |
| 23-173-06-07 | 24 CM | In distribution |
| 23-154-06-07 | 20 CM | In distribution |
| 23-155-19-07 | 20.5 CM | In distribution |
| 48-274-20-07 | 20 CM | In distribution |
| 23-139-30-07 | 24 CM | In distribution |
| 48-271-03-07 | 16 CM | In distribution |
| 37-607-06-07 | 18.5 CM | In distribution |
| 00-102-13-07 | 15 CM | In distribution |
| 09-515-23-07 | 20 CM | In distribution |
| 01-107-04-07 | 17 CM | In distribution |
| 37-606-12-07 | 18.5 CM | In distribution |
| 01-107-07-07 | 18 CM | In distribution |
| 96-233-54-07 | 15 CM | In distribution |
| 23-100-10-07 | 13.5 CM | In distribution |
| 38-786-12-07 | 16 CM | In distribution |
| 38-797-06-07 | 18 CM | In distribution |
| 23-155-06-07 | 20.5 CM | In distribution |
| 48-270-07-07 | 16 CM | In distribution |
| 01-011-00-07 | 18 CM | In distribution |
| 23-136-06-07 | 13 CM | In distribution |
| 38-791-03-07 | 17 CM | In distribution |
| 37-624-01-07 | 16 CM | In distribution |
| 38-895-08-07 | 18 CM | In distribution |
| 99-570-37-05 | In distribution | |
| 37-626-07-07 | 15 CM | In distribution |
| 38-805-08-07 | 20 CM | In distribution |
| 23-139-38-07 | 24 CM | In distribution |
| 23-138-15-07 | 24 CM | In distribution |
| 48-345-18-07 | 18 CM | In distribution |
| 38-684-33-07 | 18.5 CM | In distribution |
| 23-134-20-04 | 22 CM | In distribution |
| 38-684-32-07 | 17.5 CM | In distribution |
| 48-341-18-07 | 18 CM | In distribution |
| 38-684-37-04 | 22.5 CM | In distribution |
| 23-162-03-07 | 17 CM | In distribution |
| 23-138-30-07 | 24 CM | In distribution |
| 00-102-16-07 | 15 CM | In distribution |
| 23-170-06-07 | 24 CM | In distribution |
| 23-170-13-07 | 24 CM | In distribution |
| 38-656-24-07 | 23 CM | In distribution |
| 23-162-06-07 | 17 CM | In distribution |
| 99-570-37-04 | In distribution | |
| 23-170-25-07 | 24 CM | In distribution |
| 37-608-04-07 | 18.5 CM | In distribution |
| 23-124-20-07 | 20 CM | In distribution |
| 48-274-15-07 | 20 CM | In distribution |
| 38-786-16-07 | 16 CM | In distribution |
| 23-124-10-07 | 20 CM | In distribution |
| 23-132-10-07 | 18 CM | In distribution |
| 38-790-08-07 | 17 CM | In distribution |
| 38-684-35-07 | 19 CM | In distribution |
| 23-132-04-04 | 18 CM | In distribution |
| 99-583-38-02 | 16 CM | In distribution |
| 23-136-62-07 | 17 CM | In distribution |
| 38-883-15-07 | 19 CM | In distribution |
| 23-170-19-07 | 24 CM | In distribution |
| 23-132-12-04 | 18 CM | In distribution |
| 23-136-10-07 | 13 CM | In distribution |
| 23-162-05-07 | 17 CM | In distribution |
| 00-102-11-07 | 15 CM | In distribution |
| 23-132-10-04 | 18 CM | In distribution |
| 38-780-00-07 | 20.5 CM | In distribution |
| 99-570-37-02 | In distribution | |
| 37-610-16-07 | 18 CM | In distribution |
| 37-623-07-07 | 17 CM | In distribution |
| 37-625-03-07 | 20 CM | In distribution |
| 37-625-02-07 | 20 CM | In distribution |
| 23-139-15-07 | 24 CM | In distribution |
| 00-102-18-07 | 15 CM | In distribution |
| 23-139-20-07 | 24 CM | In distribution |
| 23-100-12-07 | 13.5 CM | In distribution |
| 38-786-06-07 | 16 CM | In distribution |
| 38-786-04-07 | 16 CM | In distribution |
| 23-138-38-07 | 24 CM | In distribution |
| 995-3287-01 | 23 CM | In distribution |
| 38-802-04-07 | 18.5 CM | In distribution |
| 38-790-04-07 | 17 CM | In distribution |
| 37-606-09-07 | 18.5 CM | In distribution |
| 01-107-02-07 | 17 CM | In distribution |
| 23-136-58-07 | 17 CM | In distribution |
| 23-173-13-07 | 24 CM | In distribution |
| 38-799-06-07 | 18 CM | In distribution |
| 38-899-08-07 | 21 CM | In distribution |
| 48-274-06-07 | 20 CM | In distribution |
| 00-102-14-07 | 15 CM | In distribution |
| 37-626-12-07 | 15 CM | In distribution |
| 38-883-07-07 | 19 CM | In distribution |
| 23-136-08-07 | 13 CM | In distribution |
| 37-606-04-07 | 18.5 CM | In distribution |
| 48-166-11-07 | 23 CM | In distribution |
| 38-684-38-04 | 22.5 CM | In distribution |
| 38-790-06-07 | 17 CM | In distribution |
| 38-781-00-07 | 20.5 CM | In distribution |
| 00-102-17-07 | 15 CM | In distribution |
| 48-275-10-07 | 20 CM | In distribution |
| 48-728-18-07 | 18 CM | In distribution |
| 38-786-08-07 | 16 CM | In distribution |
| 37-623-04-07 | 17 CM | In distribution |
| 995-3994-02 | 19 CM | In distribution |
| 48-276-10-07 | 16 CM | In distribution |
| 995-3994-04 | 19 CM | In distribution |
| 48-271-10-07 | 16 CM | In distribution |
| 99-570-37-01 | In distribution | |
| 37-626-10-07 | 15 CM | In distribution |
| 50-440-06-07 | 18.5 CM | In distribution |
| 37-626-06-07 | 15 CM | In distribution |
| 38-856-19-07 | 19 CM | In distribution |
| 37-626-01-07 | 15 CM | In distribution |
| 37-624-14-07 | 16 CM | In distribution |
| 37-625-01-07 | 20 CM | In distribution |
| 48-166-08-07 | 23 CM | In distribution |
| 48-275-20-07 | 20 CM | In distribution |
| 37-624-12-07 | 16 CM | In distribution |
| 37-626-04-07 | 15 CM | In distribution |
| 37-609-06-07 | 18.5 CM | In distribution |
| 48-270-10-07 | 16 CM | In distribution |
| 23-155-09-07 | 20.5 CM | In distribution |
| 01-107-08-07 | 18 CM | In distribution |
| 48-270-16-07 | 16 CM | In distribution |
| 23-162-08-07 | 17 CM | In distribution |
| 38-786-14-07 | 16 CM | In distribution |
| 38-784-23-04 | 23 CM | In distribution |
| 38-783-01-07 | 17.5 CM | In distribution |
| 23-134-20-07 | 22 CM | In distribution |
| 37-626-18-07 | In distribution | |
| 37-628-02-07 | 18 CM | In distribution |
| 23-100-08-07 | 13.5 CM | In distribution |
| 23-139-06-07 | 24 CM | In distribution |
| 38-802-03-07 | 20 CM | In distribution |
| 37-623-06-07 | 17 CM | In distribution |
| 37-623-05-07 | 17 CM | In distribution |
| 37-608-07-07 | 18.5 CM | In distribution |
| 995-3994-03 | 19 CM | In distribution |
| 23-154-19-07 | 20 CM | In distribution |
| 48-167-08-07 | 21 CM | In distribution |
| 23-136-60-07 | 17 CM | In distribution |
| 01-107-05-07 | 18 CM | In distribution |
| 38-791-01-07 | 16.5 CM | In distribution |
| 23-173-25-07 | 24 CM | In distribution |
| 48-156-04-07 | 18 CM | In distribution |
| 38-802-02-07 | 20 CM | In distribution |
| 48-156-08-07 | 19 CM | In distribution |
| 23-136-02-07 | 13 CM | In distribution |
| 99-594-57-01 | 16.5 CM | In distribution |
| 48-270-14-07 | 16 CM | In distribution |
| 37-624-02-07 | 16 CM | In distribution |
| 37-616-12-07 | 18.5 CM | In distribution |
| 00-105-82-07 | 20 CM | In distribution |
| 38-899-06-07 | 20 CM | In distribution |
| 38-881-10-07 | 17 CM | In distribution |
| 37-626-05-07 | 15 CM | In distribution |
| 01-003-50-07 | In distribution | |
| 37-619-03-07 | 17 CM | In distribution |
| 23-173-32-07 | 24 CM | In distribution |
| 23-132-06-04 | 18 CM | In distribution |
| 23-136-56-07 | 17 CM | In distribution |
| 38-807-15-07 | 18 CM | In distribution |
| 96-233-52-07 | 15 CM | In distribution |
| 37-624-10-07 | 16 CM | In distribution |
| 23-136-54-07 | 17 CM | In distribution |
| 38-807-20-07 | 18 CM | In distribution |
| 23-139-25-07 | 24 CM | In distribution |
| 48-271-07-07 | 16 CM | In distribution |
| 37-624-16-07 | 16 CM | In distribution |
| 48-273-10-07 | 18 CM | In distribution |
| 50-440-04-07 | 18.5 CM | In distribution |
| 23-136-52-07 | 17 CM | In distribution |
| 38-793-01-07 | 16.5 CM | In distribution |
| 48-156-06-07 | 18.5 CM | In distribution |
| 48-274-10-07 | 20 CM | In distribution |
| 23-136-15-07 | 13 CM | In distribution |
| 23-134-07-07 | 22 CM | In distribution |
| 38-786-10-07 | 16 CM | In distribution |
| 38-881-07-07 | 17 CM | In distribution |
| 48-270-05-07 | 16 CM | In distribution |
| 37-606-07-07 | 18.5 CM | In distribution |
| 38-807-10-07 | 18 CM | In distribution |
| 23-124-25-07 | 20 CM | In distribution |
| 23-155-13-07 | 20.5 CM | In distribution |
| 23-139-44-07 | 24 CM | In distribution |
| 01-107-06-07 | 18 CM | In distribution |
| 23-134-15-04 | 22 CM | In distribution |
| 48-276-15-07 | 16 CM | In distribution |
| 38-895-05-07 | 18 CM | In distribution |
| 99-570-37-03 | In distribution | |
| 23-138-20-07 | 24 CM | In distribution |
| 96-233-58-07 | 15 CM | In distribution |
| 23-136-53-07 | 17 CM | In distribution |
| 38-781-01-07 | 20.5 CM | In distribution |
| 48-274-12-07 | 20 CM | In distribution |
| 23-134-07-04 | 22 CM | In distribution |
| 37-616-10-07 | 18.5 CM | In distribution |
| 38-802-01-07 | 20 CM | In distribution |
| 01-107-03-07 | 17 CM | In distribution |
| 48-340-18-07 | 18.5 CM | In distribution |
| 23-136-03-07 | 13 CM | In distribution |
| 37-626-03-07 | 15 CM | In distribution |
| 38-311-23-04 | 22 CM | In distribution |
| 48-270-02-07 | 16 CM | In distribution |
| 23-170-32-07 | 24 CM | In distribution |
| 37-628-01-07 | 18 CM | In distribution |
| 01-105-50-07 | 18 CM | In distribution |
| 37-628-03-07 | 18 CM | In distribution |
| 37-616-14-07 | 18.5 CM | In distribution |
| 23-132-08-04 | 18 CM | In distribution |
| 23-136-65-07 | 17 CM | In distribution |
| 48-274-30-07 | 20 CM | In distribution |
| 23-155-25-07 | 20.5 CM | In distribution |
| 23-138-25-07 | 24 CM | In distribution |
| 23-100-16-07 | 13.5 CM | In distribution |
| 38-797-04-07 | 18 CM | In distribution |
| 03-400-11-07 | 18 CM | In distribution |
| 38-802-08-07 | 18.5 CM | In distribution |
| 38-841-22-07 | 22 CM | In distribution |
| 37-626-02-07 | 15 CM | In distribution |
| 99-557-38-01 | 23 CM | In distribution |
| 50-440-08-07 | 18.5 CM | In distribution |
| 38-793-03-07 | 16.5 CM | In distribution |
| 23-138-44-07 | 24 CM | In distribution |
| 01-107-01-07 | 17 CM | In distribution |
| 23-134-10-04 | 22 CM | In distribution |
| 38-684-34-07 | 19.5 CM | In distribution |
| 50-441-06-07 | 18.5 CM | In distribution |
| 38-796-06-07 | 18 CM | In distribution |
| 00-102-15-07 | 15 CM | In distribution |
| 23-154-09-07 | 20 CM | In distribution |
| 23-139-50-07 | 24 CM | In distribution |
| 48-542-11-07 | 18 CM | In distribution |
| 23-136-04-07 | 13 CM | In distribution |
| 23-136-12-07 | 13 CM | In distribution |
| 48-272-18-07 | 16 CM | In distribution |
| 23-100-14-07 | 13.5 CM | In distribution |
| 38-796-08-07 | 18 CM | In distribution |
| 38-796-04-07 | 18 CM | In distribution |
| 48-275-15-07 | 20 CM | In distribution |
| 23-162-09-07 | 17 CM | In distribution |
Showing 250 of 262 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 300 |
| Life Instruments | Life Instrument Corp. | 283 |
| Boss Instruments | Boss Instruments, Ltd. | 249 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 243 |
| Innomed, Inc. | Innomed, Inc. | 241 |
| Ambler Surgical | Ambler Surgical, LLC | 226 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 225 |
| Novo Surgical | Novo Surgical, Inc. | 213 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 177 |
| Osteotome | Biomet Microfixation | 170 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 158 |
| Zoll-Dental | Zoll-Dental | 132 |
Showing 12 of 279. All products under Osteotome
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.