SeaSpine® Spacer System – Redondo
Redondo Rasp, 26mm x 24mm x 16mm, 5 Deg Lordotic
12manufacturers in China registered for this device type
46catalogue 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 | 2016-05-02 |
| Record revised | 2025-10-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 93-6316 | 26mm x 24mm x 16mm, 5 Deg | In distribution |
| 93-6364 | 34mm x 24mm x 10mm, 12 Deg | In distribution |
| 93-6362 | 34mm x 24mm x 22mm, 8 Deg | In distribution |
| 93-6376 | 34mm x 24mm x 22mm, 12 Deg | In distribution |
| 93-6368 | 34mm x 24mm x 14mm, 12 Deg | In distribution |
| 93-6318 | 26mm x 24mm x 18mm, 5 Deg | In distribution |
| 93-6332 | 30mm x 24mm x 12mm, 5 Deg | In distribution |
| 93-6334 | 30mm x 24mm x 14mm, 5 Deg | In distribution |
| 93-6458 | 38mm x 26mm 16mm, 12 Deg | In distribution |
| 93-6446 | 38mm x 26mm x 18mm, 8 Deg | In distribution |
| 93-6360 | 34mm x 24mm x 20mm, 8 Deg | In distribution |
| 93-6358 | 34mm x 24mm x 18mm, 8 Deg | In distribution |
| 93-6370 | 34mm x 24mm x 16mm, 12 Deg | In distribution |
| 93-6320 | 26mm x 24mm x 20mm, 5 Deg | In distribution |
| 93-6336 | 30mm x 24mm x 16mm, 5 Deg | In distribution |
| 93-6454 | 38mm x 26mm 12mm, 12 Deg | In distribution |
| 93-6158 | 15 in x 18mm | In distribution |
| 93-6374 | 34mm x 24mm x 20mm, 12 Deg | In distribution |
| 93-6356 | 34mm x 24mm x 16mm, 8 Deg | In distribution |
| 93-6442 | 38mm x 26mm x 14mm, 8 Deg | In distribution |
| 93-6450 | 38mm x 26mm x 22mm, 8 Deg | In distribution |
| 93-6156 | 15 in x 16mm | In distribution |
| 93-6154 | 15 in x 14mm | In distribution |
| 93-6462 | 38mm x 26mm 20mm, 12 Deg | In distribution |
| 93-6440 | 38mm x 26mm x 12mm, 8 Deg | In distribution |
| 93-6444 | 38mm x 26mm x 16mm, 8 Deg | In distribution |
| 93-6464 | 38mm x 26mm 22mm, 12 Deg | In distribution |
| 93-6438 | 38mm x 26mm x 10mm, 8 Deg | In distribution |
| 93-6310 | 26mm x 24mm x 10mm, 5 Deg | In distribution |
| 93-6372 | 34mm x 24mm x 18mm, 12 Deg | In distribution |
| 93-6340 | 30mm x 24mm x 20mm, 5 Deg | In distribution |
| 93-6338 | 30mm x 24mm x 18mm, 5 Deg | In distribution |
| 93-6366 | 34mm x 24mm x 12mm, 12 Deg | In distribution |
| 93-6330 | 30mm x 24mm x 10mm, 5 Deg | In distribution |
| 93-6152 | 15 in x 12mm | In distribution |
| 93-6133 | In distribution | |
| 93-6352 | 34mm x 24mm x 12mm, 8 Deg | In distribution |
| 93-6314 | 26mm x 24mm x 14mm, 5 Deg | In distribution |
| 93-6456 | 38mm x 26mm 14mm, 12 Deg | In distribution |
| 93-6150 | 15 in x 10mm | In distribution |
| 93-6354 | 34mm x 24mm x 14mm, 8 Deg | In distribution |
| 93-6460 | 38mm x 26mm 18mm, 12 Deg | In distribution |
| 93-6312 | 26mm x 24mm x 12mm, 5 Deg | In distribution |
| 93-6350 | 34mm x 24mm x 10mm, 8 Deg | In distribution |
| 93-6448 | 38mm x 26mm x 20mm, 8 Deg | In distribution |
| 93-6452 | 38mm x 26mm 10mm, 12 Deg | 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.