Shoreline™ ACS
Trial Rasp, 14x13x11mm, 7 Deg Lordosis
12manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-19 |
| Record revised | 2025-10-24 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 86-3307 | In distribution | |
| 86-3011 | In distribution | |
| 86-3207 | In distribution | |
| 86-3006 | In distribution | |
| 86-3005 | In distribution | |
| 86-3208 | In distribution | |
| 86-3211 | In distribution | |
| 86-3007 | In distribution | |
| 86-3309 | In distribution | |
| 86-3012 | In distribution | |
| 86-3305 | In distribution | |
| 86-3010 | In distribution | |
| 86-3108 | 16x14x8mm, 7 Deg | In distribution |
| 86-3310 | In distribution | |
| 86-3009 | In distribution | |
| 86-3308 | In distribution | |
| 86-3110 | 16x14x10mm, 7 Deg | In distribution |
| 86-3106 | 16x14x6mm, 7 Deg | In distribution |
| 86-3107 | 16x14x7mm, 7 Deg | In distribution |
| 86-3112 | 16x14x12mm, 7 Deg | In distribution |
| 86-3209 | In distribution | |
| 86-3212 | In distribution | |
| 86-3105 | 16x14x5mm, 7 Deg | In distribution |
| 86-3109 | 16x14x9mm, 7 Deg | In distribution |
| 86-3210 | In distribution | |
| 86-3306 | In distribution | |
| 86-3111 | 16x14x11mm, 7 Deg | In distribution |
| 86-3206 | In distribution | |
| 86-3205 | In distribution | |
| 86-3312 | In distribution | |
| 86-3311 | In distribution | |
| 86-3008 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 240 |
| TiWAVE C Cervical Cage System | Kalitec Direct, LLC | 232 |
| Tranquil-C™ | Nexus Spine, L.L.C. | 158 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 143 |
| Rasp | Medtronic Sofamor Danek, Inc. | 109 |
| Specials | Seaspine Orthopedics Corporation | 109 |
| Stryker | Avalign Technologies, Inc. | 105 |
| Endoskeleton® TAS | Medtronic Sofamor Danek, Inc. | 93 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 90 |
| Cambria | Seaspine Orthopedics Corporation | 85 |
| IdentiTi | Alphatec Spine, Inc. | 83 |
| Link Instruments – Rasps, compressors and broaches | Waldemar Link GmbH & Co. KG | 83 |
Showing 12 of 378. All products under Rasp
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.