Pisces-SA
26x35x09, 8°, Sterile, Standalone ALIF Interbody, PISCES-SA
3manufacturers in China registered for this device type
56catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Osseus Fusion Systems LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213935 |
| Record published | 2022-05-18 |
| Record revised | 2025-07-14 (version 4) |
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 |
| Distribution end date | 2022-05-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1700-M098 | In distribution | |
| 1720-5040 | In distribution | |
| 1720-5118 | In distribution | |
| 1720-5048 | In distribution | |
| 1720-5153 | In distribution | |
| 1720-5120 | In distribution | |
| 1720-5638 | In distribution | |
| 1720-5050 | In distribution | |
| 1720-5018 | In distribution | |
| 1720-5628 | In distribution | |
| 1720-5618 | In distribution | |
| 1720-5145 | In distribution | |
| 1720-5643 | In distribution | |
| 1720-0001 | In distribution | |
| 1720-5138 | In distribution | |
| 1720-5422 | In distribution | |
| 1720-5648 | In distribution | |
| 1720-5020 | In distribution | |
| 1720-5425 | In distribution | |
| 1720-5645 | In distribution | |
| 1720-5140 | In distribution | |
| 1720-5030 | In distribution | |
| 1720-5125 | In distribution | |
| 1720-5635 | In distribution | |
| 1760-7013 | In distribution | |
| 1720-5633 | In distribution | |
| 1720-5640 | In distribution | |
| 1720-5630 | In distribution | |
| 1720-5133 | In distribution | |
| 1720-5028 | In distribution | |
| 1720-5143 | In distribution | |
| 1720-5053 | In distribution | |
| 1720-5135 | In distribution | |
| 1720-5650 | In distribution | |
| 1720-5123 | In distribution | |
| 1720-5045 | In distribution | |
| 1720-5035 | In distribution | |
| 1720-5015 | In distribution | |
| 1720-5620 | In distribution | |
| 1720-5623 | In distribution | |
| 1720-5025 | In distribution | |
| 1720-5128 | In distribution | |
| 1720-5625 | In distribution | |
| 1720-5615 | In distribution | |
| 1760-7011 | In distribution | |
| 1760-7010 | In distribution | |
| 1720-5043 | In distribution | |
| 1720-5148 | In distribution | |
| 1790-0001 | In distribution | |
| 1720-5653 | In distribution | |
| 1720-5130 | In distribution | |
| 1720-5150 | In distribution | |
| 1720-5033 | In distribution | |
| 1720-5115 | In distribution | |
| 1720-5038 | Withdrawn | |
| 1720-5023 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223413 | 2023-02-10 |
| K213935 | 2022-05-06 |
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.