Aspen MIS Fusion System
57 catalogue numbers from 6251-0006-001, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
57catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2015-10-24 |
| Record revised | 2025-01-03 (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 |
|---|---|---|
| 6251-0006-001 | LOCK PLATE FLARED TI 6MM | In distribution |
| 6251-0006-003 | PLATE-POST BODY FLARED TI 6MM | In distribution |
| 6213-0008-003 | PLATE-POST BODY NARROW TI 8MM | In distribution |
| 6212-0008-003 | PLATE-POST BODY MEDIUM TI 8MM | In distribution |
| 6252-0010-003 | MEDIUM FLARED PLATE-POST BODY TI 10MM | In distribution |
| 6251-0016-001 | LOCK PLATE FLARED TI 16MM | In distribution |
| 6251-0014-001 | LOCK PLATE FLARED TI 14MM | In distribution |
| 6252-0018-003 | MEDIUM FLARED PLATE-POST BODY TI 18MM | In distribution |
| 6212-0006-003 | PLATE-POST BODY MEDIUM TI 6MM | In distribution |
| 6201-1008-001 | LOCK PLATE SHORT TI 8MM | In distribution |
| 6201-1006-001 | LOCK PLATE SHORT TI 6MM | In distribution |
| 6201-0012-001 | LOCK-PLATE TI 12MM | In distribution |
| 6211-0018-003 | PLATE-POST BODY WIDE TI 18MM | In distribution |
| 6212-0018-003 | PLATE-POST BODY MEDIUM TI 18MM | In distribution |
| 6251-0010-003 | PLATE-POST BODY FLARED TI 10MM | In distribution |
| 6211-0012-003 | PLATE-POST BODY WIDE TI 12MM | In distribution |
| 6201-1012-001 | LOCK PLATE SHORT TI 12MM | In distribution |
| 6211-1006-003 | PLATE-POST SHORT WIDE TI 6MM | In distribution |
| 6213-0006-003 | PLATE-POST BODY NARROW TI 6MM | In distribution |
| 6201-0010-001 | LOCK-PLATE TI 10MM | In distribution |
| 6201-0008-001 | LOCK-PLATE TI 8MM | In distribution |
| 6201-0006-001 | LOCK-PLATE TI 6MM | In distribution |
| 6213-0014-003 | PLATE-POST BODY NARROW TI 14MM | In distribution |
| 6212-0014-003 | PLATE-POST BODY MEDIUM TI 14MM | In distribution |
| 6201-1010-001 | LOCK PLATE SHORT TI 10MM | In distribution |
| 6251-0010-001 | LOCK PLATE FLARED TI 10MM | In distribution |
| 6251-0012-003 | PLATE-POST BODY FLARED TI 12MM | In distribution |
| 6252-0008-003 | MEDIUM FLARED PLATE-POST BODY TI 08MM | In distribution |
| 6251-0014-003 | PLATE-POST BODY FLARED TI 14MM | In distribution |
| 6213-0010-003 | PLATE-POST BODY NARROW TI 10MM | In distribution |
| 6211-1012-003 | PLATE-POST SHORT WIDE TI 12MM | In distribution |
| 6211-0008-003 | PLATE-POST BODY WIDE TI 8MM | In distribution |
| 6211-1008-003 | PLATE-POST SHORT WIDE TI 8MM | In distribution |
| 6211-1010-003 | PLATE-POST SHORT WIDE TI 10MM | In distribution |
| 6201-0016-001 | LOCK-PLATE TI 16MM | In distribution |
| 6251-0016-003 | PLATE-POST BODY FLARED TI 16MM | In distribution |
| 6213-0016-003 | PLATE-POST BODY NARROW TI 16MM | In distribution |
| 6212-0016-003 | PLATE-POST BODY MEDIUM TI 16MM | In distribution |
| 6252-0012-003 | MEDIUM FLARED PLATE-POST BODY TI 12MM | In distribution |
| 6213-0018-003 | PLATE-POST BODY NARROW TI 18MM | In distribution |
| 6252-0016-003 | MEDIUM FLARED PLATE-POST BODY TI 16MM | In distribution |
| 6211-0014-003 | PLATE-POST BODY WIDE TI 14MM | In distribution |
| 6251-0008-003 | PLATE-POST BODY FLARED TI 8MM | In distribution |
| 6211-0006-003 | PLATE-POST BODY WIDE TI 6MM | In distribution |
| 6251-0012-001 | LOCK PLATE FLARED TI 12MM | In distribution |
| 6251-0008-001 | LOCK PLATE FLARED TI 8MM | In distribution |
| 6251-0018-001 | LOCK PLATE FLARED TI 18MM | In distribution |
| 6212-0010-003 | PLATE-POST BODY MEDIUM TI 10MM | In distribution |
| 6252-0014-003 | MEDIUM FLARED PLATE-POST BODY TI 14MM | In distribution |
| 6201-0014-001 | LOCK-PLATE TI 14MM | In distribution |
| 6211-0010-003 | PLATE-POST BODY WIDE TI 10MM | In distribution |
| 6251-0018-003 | PLATE-POST BODY FLARED TI 18MM | In distribution |
| 6201-0018-001 | LOCK-PLATE TI 18MM | In distribution |
| 6252-0006-003 | MEDIUM FLARED PLATE-POST BODY TI 06MM | In distribution |
| 6211-0016-003 | PLATE-POST BODY WIDE TI 16MM | In distribution |
| 6212-0012-003 | PLATE-POST BODY MEDIUM TI 12MM | In distribution |
| 6213-0012-003 | PLATE-POST BODY NARROW TI 12MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.