Sklar®
Censitrac Ready Nail Nipp Concv Barr Sprg 4.5 Inches
17manufacturers in China registered for this device type
93catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (3), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Ningbo Huakun Medical Equipment Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 19 |
Showing 12 of 17. All 17 manufacturers in China registered for Cutter, Surgical
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | FZT |
| Device type | Cutter, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-24 |
| Record revised | 2019-08-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 24-2350 | In distribution | ||
| 97-1045C | In distribution | ||
| 98-476 | In distribution | ||
| 97-1242C | In distribution | ||
| 97-1255 | In distribution | ||
| 97-1156C | In distribution | ||
| 97-1308 | In distribution | ||
| 95-489 | In distribution | ||
| 98-489 | In distribution | ||
| 98-491 | In distribution | ||
| 23-9292 | In distribution | ||
| 95-488 | In distribution | ||
| 97-1243 | In distribution | ||
| 97-1308C | In distribution | ||
| 98-483 | In distribution | ||
| 21-493 | 12 | In distribution | |
| 23-9273 | In distribution | ||
| 97-1046 | In distribution | ||
| 97-1056C | In distribution | ||
| 97-1243C | In distribution | ||
| 98-475 | In distribution | ||
| 97-1155 | In distribution | ||
| 95-493 | In distribution | ||
| 97-1185C | In distribution | ||
| 97-1055 | In distribution | ||
| 97-1055C | In distribution | ||
| 97-0474 | In distribution | ||
| 98-478 | In distribution | ||
| 97-1309 | In distribution | ||
| 24-2350C | In distribution | ||
| 97-1057 | In distribution | ||
| 97-1057C | In distribution | ||
| 97-1286C | In distribution | ||
| 21-483 | 12 | In distribution | |
| 97-1286 | In distribution | ||
| 23-9255 | In distribution | ||
| 98-480 | In distribution | ||
| 97-1280 | In distribution | ||
| 23-9276 | In distribution | ||
| 97-1309C | In distribution | ||
| 95-491 | In distribution | ||
| 97-0335 | In distribution | ||
| 98-477 | In distribution | ||
| 97-1045 | In distribution | ||
| 97-1156 | In distribution | ||
| 97-1056 | In distribution | ||
| 23-9259 | In distribution | ||
| 97-1251 | In distribution | ||
| 21-486 | 12 | In distribution | |
| 95-497 | In distribution | ||
| 23-9275 | In distribution | ||
| 23-9250 | In distribution | ||
| 98-484 | In distribution | ||
| 97-1150 | In distribution | ||
| 95-484 | In distribution | ||
| 97-1030 | In distribution | ||
| 97-1261 | In distribution | ||
| 97-1238 | In distribution | ||
| 95-486 | In distribution | ||
| 97-1150C | In distribution | ||
| 97-1259 | In distribution | ||
| 97-1046C | In distribution | ||
| 97-1031 | In distribution | ||
| 97-1241 | In distribution | ||
| 23-9251 | In distribution | ||
| 97-1174C | In distribution | ||
| 97-1174 | In distribution | ||
| 97-1285 | In distribution | ||
| 21-497 | 12 | In distribution | |
| 97-1148 | In distribution | ||
| 98-482 | In distribution | ||
| 95-472 | In distribution | ||
| 97-1146 | In distribution | ||
| 98-485 | In distribution | ||
| 97-1251C | In distribution | ||
| 21-472 | 12 | In distribution | |
| 98-493 | In distribution | ||
| 21-484 | 12 | In distribution | |
| 97-1185 | In distribution | ||
| 21-475 | 12 | In distribution | |
| 98-472 | In distribution | ||
| 21-489 | 12 | In distribution | |
| 97-1259C | In distribution | ||
| 97-1148C | In distribution | ||
| 21-482 | 12 | In distribution | |
| 97-1242 | In distribution | ||
| 97-1145C | In distribution | ||
| 97-1262 | In distribution | ||
| 97-1145 | In distribution | ||
| 95-482 | In distribution | ||
| 97-1240 | In distribution | ||
| 21-479 | 12 | In distribution | |
| 98-497 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 326 |
| Tecomet | Tecomet, Inc. | 89 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 46 |
| Aesculap | Aesculap AG | 38 |
| Orthomed | Ortho-MED, Inc. | 37 |
| Surtex | Surtex Instruments Ltd | 35 |
| SeaSpine Spacer System – Pacifica | Seaspine Orthopedics Corporation | 24 |
| Millennium | Avalign Technologies, Inc. | 23 |
| Cutter, Surgical | Medtronic Sofamor Danek, Inc. | 22 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 22 |
| Velofix™ PEEK Lumbar Cage | CG MedTech Co., Ltd. | 20 |
| Skyhawk | Orthofix US LLC | 19 |
Showing 12 of 177. All products under Cutter, Surgical
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 |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 7730 units |
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.