Half Dome
CUP Curette, Bayonette, Straight, #2, Teeth
3manufacturers in China registered for this device type
77catalogue numbers in this listing
3510(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 | Astura Medical, 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, Complaint-file establishment, Manufacturer |
| Record published | 2022-08-31 |
| Record revised | 2025-12-10 (version 4) |
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 |
| Sizes | Width 3 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BZ1000010 | In distribution | |
| BZ0400011 | Width 11 mm | In distribution |
| BZ0400004 | Width 4 mm | In distribution |
| CUST-00063-BZ0400011 | Width 11 mm | In distribution |
| BZ6924009 | Width 9 mm | In distribution |
| BZ7026007 | Width 7 mm | In distribution |
| BZ0400007 | Width 7 mm | In distribution |
| BZ0400015 | Width 15 mm | In distribution |
| BZ6924015 | Width 15 mm | In distribution |
| BZ1100000 | In distribution | |
| BZ1000000 | In distribution | |
| BZ1200010 | In distribution | |
| BZ5100012 | In distribution | |
| CUST-00063-BZ0400012 | Width 12 mm | In distribution |
| BZ1400000 | In distribution | |
| BZ0300009 | Width 9 mm | In distribution |
| CUST-00063-BZ0400015 | Width 15 mm | In distribution |
| BZ1000030 | In distribution | |
| BZ0300003 | Width 3 mm | In distribution |
| BZ6924010 | Width 10 mm | In distribution |
| BZ7026008 | Width 8 mm | In distribution |
| BZ1300000 | In distribution | |
| BZ0300005 | Width 5 mm | In distribution |
| BZ5300002 | In distribution | |
| BZ5300000 | In distribution | |
| BZ5200000 | In distribution | |
| BZ7026006 | Width 6 mm | In distribution |
| BZ6924011 | Width 11 mm | In distribution |
| BZ7026013 | Width 13 mm | In distribution |
| BZ0300012 | Width 12 mm | In distribution |
| BZ5000000 | In distribution | |
| BZ0400003 | Width 3 mm | In distribution |
| BZ6924006 | Width 6 mm | In distribution |
| CUST-00063-BZ0400007 | Width 7 mm | In distribution |
| CUST-00063-BZ0400010 | Width 10 mm | In distribution |
| BZ0300010 | Width 10 mm | In distribution |
| BZ0400008 | Width 8 mm | In distribution |
| BZ7026014 | Width 14 mm | In distribution |
| BZ0300011 | Width 11 mm | In distribution |
| BZ0400013 | Width 13 mm | In distribution |
| BZ7026015 | Width 15 mm | In distribution |
| BZ0400005 | Width 5 mm | In distribution |
| BZ0300014 | Width 14 mm | In distribution |
| BZ0300008 | Width 8 mm | In distribution |
| BZ5100000 | In distribution | |
| CUST-00063-BZ0400013 | Width 13 mm | In distribution |
| BZ7026009 | Width 9 mm | In distribution |
| BZ0400010 | Width 10 mm | In distribution |
| BZ6924013 | Width 13 mm | In distribution |
| BZ0300015 | Width 15 mm | In distribution |
| BZ7026010 | Width 10 mm | In distribution |
| BZ5200002 | In distribution | |
| BZ0300013 | Width 13 mm | In distribution |
| BZ1600000 | In distribution | |
| CUST-00063-BZ0400008 | Width 8 mm | In distribution |
| BZ6924014 | Width 14 mm | In distribution |
| BZ0300006 | Width 6 mm | In distribution |
| CUST-00063-BZ0400009 | Width 9 mm | In distribution |
| BZ7026012 | Width 12 mm | In distribution |
| BZ0400006 | Width 6 mm | In distribution |
| BZ1200020 | In distribution | |
| BZ0400009 | Width 9 mm | In distribution |
| BZ6924007 | Width 7 mm | In distribution |
| BZ0400014 | Width 14 mm | In distribution |
| BZ5400000 | In distribution | |
| CUST-00063-BZ0400006 | Width 6 mm | In distribution |
| BZ5100002 | In distribution | |
| BZ0400012 | Width 12 mm | In distribution |
| BZ5100010 | In distribution | |
| BZ6924012 | Width 12 mm | In distribution |
| BZ7026011 | Width 11 mm | In distribution |
| BZ0300004 | Width 4 mm | In distribution |
| CUST-00063-BZ0400005 | Width 5 mm | In distribution |
| CUST-00063-BZ0400014 | Width 14 mm | In distribution |
| BZ1500000 | In distribution | |
| BZ6924008 | Width 8 mm | In distribution |
| BZ0300007 | Width 7 mm | In distribution |
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 |
|---|---|
| K222554 | 2023-01-19 |
| K214047 | 2022-03-30 |
| K192492 | 2020-04-21 |
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.