OsteoMed
0.6mm x 17.0mm Arced Reciprocating Saw Blade, Long Shaft, Sterile
1manufacturer
297catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
Record
| Listed by | Osteomed, United States |
|---|---|
| FDA product code | KMW |
| Device type | Handpiece, Rotary Bone Cutting |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-09-22 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Sterile packaged devices should be stored at controlled room temperature out of direct sunlight. |
| Sizes | Outer diameter 0.5 to 7 mm; length 12 to 84 mm; width 4.6 to 19 mm; height 0.25 to 12 mm; weight 1.7 to 6.62 kg; weight 44.8 to 45.2 g; length 1 to 12 ft; angle 12 ° |
| Distribution end date | 2017-01-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 320-0310 | In distribution | |
| 450-0215 | In distribution | |
| 450-0084 | In distribution | |
| 450-3040 | Outer Diameter 4 mm | In distribution |
| 455-3713 | Outer Diameter 2.1 mm | In distribution |
| 450-0360 | In distribution | |
| 450-3140-SP | Outer Diameter 4 mm | In distribution |
| 320-0382 | In distribution | |
| 450-0532 | In distribution | |
| 451-8000-SP | In distribution | |
| 450-3701-SP | Outer Diameter 1.2 mm | In distribution |
| 450-1610-SP | Width 6 mm | In distribution |
| 450-1912 | Width 9 mm | In distribution |
| 450-0082 | In distribution | |
| 455-5008 | Outer Diameter 2.3 mm | In distribution |
| 470-0012 | Weight 1.7 kg | In distribution |
| 450-2015 | Length 15.7 mm | In distribution |
| 450-0555 | In distribution | |
| 451-2026-SP | Length 26.3 mm | In distribution |
| 450-0208 | In distribution | |
| 450-2054 | Length 58 mm | In distribution |
| 450-0030 | In distribution | |
| 450-2232-SP | Length 75 mm | In distribution |
| 450-2055 | Width 13 mm | In distribution |
| 450-0436 | In distribution | |
| 320-0313 | In distribution | |
| 450-0005-02 | In distribution | |
| 450-3702-SP | Outer Diameter 1.6 mm | In distribution |
| 450-0203 | In distribution | |
| 450-8000-SP | In distribution | |
| 451-2013-SP | Length 13.8 mm | In distribution |
| 451-2015-SP | Length 15.7 mm | In distribution |
| 450-0777 | In distribution | |
| 450-6003 | Height 0.25 mm | In distribution |
| 450-0080 | In distribution | |
| 450-0261 | In distribution | |
| 220-0307 | In distribution | |
| 450-0286 | In distribution | |
| 450-3070 | Outer Diameter 7 mm | In distribution |
| 450-2012-SP | Height 4 mm | In distribution |
| 450-1830 | Length 30 mm | In distribution |
| 450-0350 | In distribution | |
| 450-3070-SP | Outer Diameter 7 mm | In distribution |
| 450-1432 | Width 14 mm | In distribution |
| 450-2015-SP | Length 15.7 mm | In distribution |
| 450-0255 | In distribution | |
| 450-1016 | Width 10 mm | In distribution |
| 455-4004 | Outer Diameter 1.4 mm | In distribution |
| 450-0301 | In distribution | |
| 220-0304 | In distribution | |
| 455-6713 | Outer Diameter 2.1 mm | In distribution |
| 450-6005-SP | Height 0.5 mm | In distribution |
| 450-0289 | In distribution | |
| 220-0306 | In distribution | |
| 450-3001-SP | Outer Diameter 0.5 mm | In distribution |
| 451-2126-SP | Length 26.3 mm | In distribution |
| 450-6003-SP | Height 0.25 mm | In distribution |
| 450-2026-SP | Length 26.3 mm | In distribution |
| 455-3006 | Outer Diameter 1.8 mm | In distribution |
| 455-3703 | Outer Diameter 2.1 mm | In distribution |
| 450-3050 | Outer Diameter 5 mm | In distribution |
| 450-1007 | Width 10 mm | In distribution |
| 450-1029-SP | Width 10 mm | In distribution |
| 455-0506 | In distribution | |
| 450-1231 | Angle 12 ° | In distribution |
| 450-0128 | In distribution | |
| 320-0307 | In distribution | |
| 450-3160 | Outer Diameter 6 mm | In distribution |
| 450-1929-SP | Width 9 mm | In distribution |
| 450-2013 | Length 13.8 mm | In distribution |
| 455-4703 | Outer Diameter 2.1 mm | In distribution |
| 450-0302 | In distribution | |
| 450-0005-03 | In distribution | |
| 450-1028 | Width 10 mm | In distribution |
| 450-6116-SP | Length 84 mm | In distribution |
| 450-5045 | Outer Diameter 4.5 mm | In distribution |
| 450-6713-SP | Outer Diameter 2.1 mm | In distribution |
| 114-2016 | Outer Diameter 2 mm | In distribution |
| 450-0420-04 | In distribution | |
| 450-1027-SP | Width 10 mm | In distribution |
| 470-0392 | Weight 44.8 g | In distribution |
| 450-1010 | Width 10 mm | In distribution |
| 450-0278-SP | Height 7 mm | In distribution |
| 220-0300 | In distribution | |
| 450-0030 | In distribution | |
| 450-6005 | Height 0.5 mm | In distribution |
| 220-0305 | In distribution | |
| 450-0241 | In distribution | |
| 450-0550 | In distribution | |
| 450-0370 | In distribution | |
| 450-6001 | In distribution | |
| 450-0435 | In distribution | |
| 450-5030-SP | Outer Diameter 3 mm | In distribution |
| 220-0313 | In distribution | |
| 450-0505 | In distribution | |
| 450-2032 | Length 32.1 mm | In distribution |
| 450-3006-SP | Outer Diameter 1.8 mm | In distribution |
| 450-3050-SP | Outer Diameter 5 mm | In distribution |
| 450-2214-SP | Height 4 mm | In distribution |
| 450-2035 | Length 27.2 mm | In distribution |
| 450-0128-12 | In distribution | |
| 450-1619-SP | Width 6 mm | In distribution |
| 451-2054-SP | Length 58.4 mm | In distribution |
| 450-0211 | In distribution | |
| 450-6140-SP | Outer Diameter 4 mm | In distribution |
| 450-0531 | In distribution | |
| 450-1019-SP | Width 10 mm | In distribution |
| 450-1007-SP | Width 10 mm | In distribution |
| 455-4006 | Outer Diameter 1.8 mm | In distribution |
| 450-0424 | In distribution | |
| 450-3120-SP | Outer Diameter 2 mm | In distribution |
| 450-0306 | In distribution | |
| 450-3713-SP | Outer Diameter 2.1 mm | In distribution |
| 455-7702 | Outer Diameter 1.6 mm | In distribution |
| 450-0021-01 | In distribution | |
| 450-1039-SP | Width 10 mm | In distribution |
| 450-1019 | Width 10 mm | In distribution |
| 110-1001 | In distribution | |
| 451-2033-SP | Length 32.7 mm | In distribution |
| 450-3101 | Outer Diameter 1 mm | In distribution |
| 450-2012 | Height 4 mm | In distribution |
| 450-0422 | In distribution | |
| 450-0421 | In distribution | |
| 450-1941-SP | Width 19 mm | In distribution |
| 220-0310 | Length 4.5 in | In distribution |
| 450-3161-SP | Outer Diameter 4 mm | In distribution |
| 455-5713 | Outer Diameter 2.1 mm | In distribution |
| 450-1010-SP | Width 10 mm | In distribution |
| 450-0206 | In distribution | |
| 450-6702-SP | Outer Diameter 1.6 mm | In distribution |
| 450-0530 | In distribution | |
| 220-0303 | In distribution | |
| 450-0434 | In distribution | |
| 451-2214-SP | Length 17 mm | In distribution |
| 450-8000 | In distribution | |
| 450-0220 | In distribution | |
| 450-0291 | In distribution | |
| 450-5040 | Outer Diameter 4 mm | In distribution |
| 470-0391 | Weight 45.2 g | In distribution |
| 451-2055-SP | Length 48.4 mm | In distribution |
| 450-0450 | In distribution | |
| 450-3116 | Outer Diameter 1.6 mm | In distribution |
| 450-1941 | Width 19 mm | In distribution |
| 111-1646 | Outer Diameter 1.6 mm | In distribution |
| 455-4702 | Outer Diameter 1.6 mm | In distribution |
| 450-1029 | Width 10 mm | In distribution |
| 450-5008-SP | Outer Diameter 2.3 mm | In distribution |
| 450-0501 | In distribution | |
| 450-3164-SP | Outer Diameter 3 mm | In distribution |
| 450-5035 | Outer Diameter 3.5 mm | In distribution |
| 470-0005 | Weight 6.62 kg | In distribution |
| 450-6703-SP | Outer Diameter 2.1 mm | In distribution |
| 450-0518 | In distribution | |
| 450-0207 | In distribution | |
| 450-0209 | In distribution | |
| 450-0125-01 | In distribution | |
| 451-2052-SP | Length 68.6 mm | In distribution |
| 450-5040-SP | Outer Diameter 4 mm | In distribution |
| 450-1626-SP | Width 6 mm | In distribution |
| 450-0084 | In distribution | |
| 455-5703 | Outer Diameter 2.1 mm | In distribution |
| 450-0284 | In distribution | |
| 450-3115-SP | Outer Diameter 1.5 mm | In distribution |
| 450-0212 | In distribution | |
| 450-1610 | Width 6 mm | In distribution |
| 451-2226-SP | Length 26.3 mm | In distribution |
| 450-0279-SP | Height 12 mm | In distribution |
| 450-0296 | In distribution | |
| 450-2050 | Length 69 mm | In distribution |
| 450-6118-SP | Length 84 mm | In distribution |
| 450-1027 | Width 10 mm | In distribution |
| 450-6004 | In distribution | |
| 450-5035-SP | Outer Diameter 3.5 mm | In distribution |
| 450-0129 | Length 1 ft | In distribution |
| 450-1016-SP | Width 10 mm | In distribution |
| 450-0005-01 | In distribution | |
| 451-2326-SP | Length 26.3 mm | In distribution |
| 450-6140 | Outer Diameter 4 mm | In distribution |
| 450-0502 | In distribution | |
| 450-0287 | In distribution | |
| 450-2052-SP | Length 69 mm | In distribution |
| 450-0232 | In distribution | |
| 450-2033-SP | Length 32.7 mm | In distribution |
| 450-1028-SP | Width 10 mm | In distribution |
| 450-0036 | In distribution | |
| 450-0536 | In distribution | |
| 450-3101-SP | Outer Diameter 1 mm | In distribution |
| 114-1634 | Outer Diameter 1.6 mm | In distribution |
| 450-0122 | In distribution | |
| 455-3560 | Outer Diameter 1.6 mm | In distribution |
| 455-3558 | Outer Diameter 1.2 mm | In distribution |
| 450-3408-SP | Outer Diameter 6 mm | In distribution |
| 450-3004-SP | Outer Diameter 1.4 mm | In distribution |
| 450-0214 | In distribution | |
| 450-0032 | In distribution | |
| 450-5702-SP | Outer Diameter 1.6 mm | In distribution |
| 450-0034 | In distribution | |
| 450-5045-SP | Outer Diameter 4.5 mm | In distribution |
| 450-0240 | In distribution | |
| 450-0204 | In distribution | |
| 450-1605-SP | Width 6 mm | In distribution |
| 455-3408 | Outer Diameter 0.236 in | In distribution |
| 450-0034 | In distribution | |
| 450-0425-SP | Width 4.6 mm | In distribution |
| 450-0380 | In distribution | |
| 451-2212-SP | Length 12 mm | In distribution |
| 450-2233-SP | Length 80 mm | In distribution |
| 220-0312 | In distribution | |
| 220-0302 | In distribution | |
| 450-3703-SP | Outer Diameter 2.1 mm | In distribution |
| 450-0277-SP | Height 12 mm | In distribution |
| 450-0287-90 | In distribution | |
| 450-0303 | In distribution | |
| 450-2215 | Length 15.7 mm | In distribution |
| 450-1619 | Width 6 mm | In distribution |
| 450-2055-SP | Width 13 mm | In distribution |
| 220-0301 | In distribution | |
| 114-2034 | Outer Diameter 2 mm | In distribution |
| 110-1000-SP | In distribution | |
| 450-5030 | Outer Diameter 3 mm | In distribution |
| 470-0390 | Weight 2.18 kg | In distribution |
| 450-3170-SP | Outer Diameter 2.3 mm | In distribution |
| 111-1601 | Outer Diameter 1.6 mm | In distribution |
| 450-3040-SP | Outer Diameter 4 mm | In distribution |
| 450-0005-00 | In distribution | |
| 450-2326 | Length 72 mm | In distribution |
| 450-3116-SP | Outer Diameter 1.6 mm | In distribution |
| 455-3008 | Outer Diameter 2.3 mm | In distribution |
| 455-4008 | Outer Diameter 2.3 mm | In distribution |
| 450-0021-02 | In distribution | |
| 450-2026 | Length 26.3 mm | In distribution |
| 320-0312 | In distribution | |
| 450-0234 | In distribution | |
| 455-3701 | Outer Diameter 1.2 mm | In distribution |
| 450-0512 | In distribution | |
| 450-2226-SP | Length 72 mm | In distribution |
| 450-0230 | In distribution | |
| 455-5702 | Outer Diameter 1.6 mm | In distribution |
| 450-2050-SP | Length 69 mm | In distribution |
| 450-1626 | Width 6 mm | In distribution |
| 450-2054-SP | Length 58 mm | In distribution |
| 110-1000-SP-02 | In distribution | |
| 450-0126-01 | Length 12 ft | In distribution |
| 450-0390 | In distribution | |
| 450-2326-SP | Length 72 mm | In distribution |
| 450-3120 | Outer Diameter 2 mm | In distribution |
| 450-0216 | In distribution | |
| 450-5703-SP | Outer Diameter 2.1 mm | In distribution |
| 455-6006 | Outer Diameter 1.8 mm | In distribution |
| 450-0212-01 | In distribution |
Showing 250 of 297 catalogue numbers.
Same Product Code
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|---|---|---|
| Ti-Max X | Nakanishi Inc. | 19 |
| Micro Surgery Handpiece | Nakanishi Inc. | 4 |
| Turning Handle | W&H Dentalwerk Bürmoos GmbH | 4 |
| SGM-ER32i | Nakanishi Inc. | 3 |
| Ti-Max | Nakanishi Inc. | 3 |
| SM3 | Osstem Implant Co., Ltd._Gasan Branch | 3 |
| SGQ-H | Nakanishi Inc. | 3 |
| Sgms-I | Nakanishi Inc. | 2 |
| S-Max M | Nakanishi Inc. | 2 |
| SGM-I | Nakanishi Inc. | 2 |
| SGM-ER16i | Nakanishi Inc. | 2 |
| SGS-ES | Nakanishi Inc. | 2 |
Showing 12 of 93. All products under Handpiece, Rotary Bone Cutting
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162544 | 2017-04-04 |
| K971692 | 1997-06-27 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-10-28 | Class II | Device Design | Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. | 533 consoles and 586 footswitches |
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.