Dolomite
Acss Screw, Self Drilling Variable Ø4.0MM Caddy
5manufacturers in China registered for this device type
607catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Astura Medical, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-07-23 |
| Record revised | 2025-12-10 (version 5) |
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 | Angle 7 to 15 °; height 5 to 12 mm; width 5 to 18 mm; length 5 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LA161412D | Width 16 mm | In distribution |
| LZFLBC11D | Width 18 mm | In distribution |
| LZFSAC09A | Angle 7 ° | In distribution |
| LZA970000-41 | Angle 15 ° | In distribution |
| LB161407B | Width 16 mm | In distribution |
| LA141212D | Width 14 mm | In distribution |
| LZA031011 | Width 11 mm | In distribution |
| LZFSAB11D | Angle 15 ° | In distribution |
| LB181509A | Width 18 mm | In distribution |
| LZFLBC05C | Width 18 mm | In distribution |
| LZFSAB06A | Angle 7 ° | In distribution |
| LZFSAB11C | Angle 13 ° | In distribution |
| LB161405D | Width 16 mm | In distribution |
| LZFSAC09C | Angle 13 ° | In distribution |
| LZFSAC12C | Angle 13 ° | In distribution |
| LZFSBA09A | Angle 7 ° | In distribution |
| LZFLBC05B | Width 18 mm | In distribution |
| LZFSBA09C | Angle 13 ° | In distribution |
| LZFLBB10A | Width 18 mm | In distribution |
| LA161407B | Width 16 mm | In distribution |
| LZA990000-10 | In distribution | |
| LB141209C | Width 14 mm | In distribution |
| LZFSAB11A | Angle 7 ° | In distribution |
| LA181509B | Width 18 mm | In distribution |
| LA141206C | Width 14 mm | In distribution |
| LZFSAA05C | Width 14 mm | In distribution |
| LZFSAC07B | Angle 10 ° | In distribution |
| LZFLBC09B | Width 18 mm | In distribution |
| LZA970000-30 | Angle 13 ° | In distribution |
| LA161412C | Width 16 mm | In distribution |
| LZFSAB05D | Angle 15 ° | In distribution |
| LZFMBB09C | Width 16 mm | In distribution |
| LA181509A | Width 18 mm | In distribution |
| LZA930000-11 | Angle 7 ° | In distribution |
| LZFSBA06D | Angle 15 ° | In distribution |
| LA141211D | Width 14 mm | In distribution |
| LZFLBB12A | Width 18 mm | In distribution |
| LZFSAB07D | Angle 15 ° | In distribution |
| LZFMBA09A | Width 16 mm | In distribution |
| LB141207C | Width 14 mm | In distribution |
| LZFSAB09C | Angle 13 ° | In distribution |
| LB141209B | Width 14 mm | In distribution |
| LA181510C | Width 18 mm | In distribution |
| LZA930000-14 | Angle 10 ° | In distribution |
| LZFSAC11B | Angle 10 ° | In distribution |
| LZFSAC08B | Angle 10 ° | In distribution |
| LZFMAA06C | Width 16 mm | In distribution |
| LZFMAA06B | Width 16 mm | In distribution |
| LZFMBB12B | Width 16 mm | In distribution |
| LA141210C | Width 14 mm | In distribution |
| LZA970000-40 | Angle 15 ° | In distribution |
| LB181508B | Width 18 mm | In distribution |
| LZFLBC06C | Width 18 mm | In distribution |
| LDA000009 | Height 9 mm | In distribution |
| LDA000008 | Height 8 mm | In distribution |
| LZFSAA11C | Angle 13 ° | In distribution |
| LB161412C | Width 16 mm | In distribution |
| LZFMBB08A | Width 16 mm | In distribution |
| LA141205B | Width 14 mm | In distribution |
| LZA030007 | Length 7 mm | In distribution |
| LZFSAA06C | Width 14 mm | In distribution |
| LZA940000-10 | In distribution | |
| LZFMBC09C | Width 16 mm | In distribution |
| LZFSAC11D | Angle 15 ° | In distribution |
| LZFLBC11B | Width 18 mm | In distribution |
| LZFLBB12C | Width 18 mm | In distribution |
| LZFSAC10D | Angle 15 ° | In distribution |
| LA161409D | Width 16 mm | In distribution |
| LA161407C | Width 16 mm | In distribution |
| LZFSAA06B | Width 14 mm | In distribution |
| LZFMBA12D | Width 16 mm | In distribution |
| LZFSBA10C | Angle 13 ° | In distribution |
| LB181508A | Width 18 mm | In distribution |
| LZFLBB11B | Width 18 mm | In distribution |
| LZA930000-54 | Angle 10 ° | In distribution |
| LA181508A | Width 18 mm | In distribution |
| LZA090000 | In distribution | |
| LZE030001 | In distribution | |
| LZFSAA07A | Width 14 mm | In distribution |
| LZFLBC10D | Width 18 mm | In distribution |
| LZFMBC09B | Width 16 mm | In distribution |
| LB141212D | Width 14 mm | In distribution |
| LB141211C | Width 14 mm | In distribution |
| LZA950000-10 | In distribution | |
| LB181510C | Width 18 mm | In distribution |
| LZA950000-50 | In distribution | |
| LA161410C | Width 16 mm | In distribution |
| LZFMBB06D | Width 16 mm | In distribution |
| LZFLBC08A | Width 18 mm | In distribution |
| LB181511D | Width 18 mm | In distribution |
| LZFMAA11D | Width 16 mm | In distribution |
| LZFLBB10B | Width 18 mm | In distribution |
| LZFMBA12A | Width 16 mm | In distribution |
| LDD000012 | Height 12 mm | In distribution |
| LZFSAA12B | Angle 10 ° | In distribution |
| LZFMAA10D | Width 16 mm | In distribution |
| LZA031008 | Width 8 mm | In distribution |
| LA161412B | Width 16 mm | In distribution |
| LZA031007 | Width 7 mm | In distribution |
| LZFMBC08B | Width 16 mm | In distribution |
| LZA990000-70 | In distribution | |
| LZFMBB12A | Width 16 mm | In distribution |
| LZA990000-40 | In distribution | |
| LZFMAA10C | Width 16 mm | In distribution |
| LZFSBB06A | Angle 7 ° | In distribution |
| LZA950000-40 | In distribution | |
| LZFSAC10A | Angle 7 ° | In distribution |
| LZFSBA05D | Angle 15 ° | In distribution |
| LZFSAC11A | Angle 7 ° | In distribution |
| LZFMBA12B | Width 16 mm | In distribution |
| LB181512B | Width 18 mm | In distribution |
| LZFSBB10B | Angle 10 ° | In distribution |
| LZFMBC06C | Width 16 mm | In distribution |
| LB141206C | Width 14 mm | In distribution |
| LZFSAA06A | Width 14 mm | In distribution |
| LZFSAC12B | Angle 10 ° | In distribution |
| LA141209D | Width 14 mm | In distribution |
| LZA970000-32 | Angle 13 ° | In distribution |
| LZFMBB05B | Width 16 mm | In distribution |
| LZFSAA10D | Angle 15 ° | In distribution |
| LZFMBB05C | Width 16 mm | In distribution |
| LZFSBA12C | Angle 13 ° | In distribution |
| LZFMBC11D | Width 16 mm | In distribution |
| LZA031012 | Width 12 mm | In distribution |
| LZFSAB06D | Angle 15 ° | In distribution |
| LZFSAB12A | Angle 7 ° | In distribution |
| LZFSAA12D | Angle 15 ° | In distribution |
| LZA970000-50 | Angle 7 ° | In distribution |
| LZFLBC12A | Width 18 mm | In distribution |
| LZFLBC05D | Width 18 mm | In distribution |
| LB161411C | Width 16 mm | In distribution |
| LZFMBB09D | Width 16 mm | In distribution |
| LZFSAC05A | Angle 7 ° | In distribution |
| LZFMAA05A | Width 16 mm | In distribution |
| LZFSAA07C | Width 14 mm | In distribution |
| LB141208B | Width 14 mm | In distribution |
| LZFMBB10D | Width 16 mm | In distribution |
| LZFSBB08B | Angle 10 ° | In distribution |
| LZA930000-16 | Angle 13 ° | In distribution |
| LZFSBB07B | Angle 10 ° | In distribution |
| LZA930000-13 | Angle 10 ° | In distribution |
| LZA950000-20 | In distribution | |
| LZFMBC07A | Width 16 mm | In distribution |
| LZA970000-51 | Angle 7 ° | In distribution |
| LA141209A | Width 14 mm | In distribution |
| LZA950000-80 | In distribution | |
| LA181512D | Width 18 mm | In distribution |
| LZFSBA10D | Angle 15 ° | In distribution |
| LZFSAC06A | Angle 7 ° | In distribution |
| LZFMBC09D | Width 16 mm | In distribution |
| LZA930000-38 | Angle 13 ° | In distribution |
| LZFSAA09C | Angle 13 ° | In distribution |
| LZFSBA08D | Angle 15 ° | In distribution |
| LA141207B | Width 14 mm | In distribution |
| LA141206D | Width 14 mm | In distribution |
| LZFSBA11B | Angle 10 ° | In distribution |
| LZFLBC08B | Width 18 mm | In distribution |
| LZA970000-71 | Angle 13 ° | In distribution |
| LA181509C | Width 18 mm | In distribution |
| LZFSAC12D | Angle 15 ° | In distribution |
| LB181511A | Width 18 mm | In distribution |
| LDD000008 | Height 8 mm | In distribution |
| LZFSBB05D | Angle 15 ° | In distribution |
| LZFSAA12C | Angle 13 ° | In distribution |
| LZA970000-61 | Angle 10 ° | In distribution |
| LZFSAA07B | Width 14 mm | In distribution |
| LB141207A | Width 14 mm | In distribution |
| LZFMAA05D | Width 16 mm | In distribution |
| LA181511C | Width 18 mm | In distribution |
| LB161410D | Width 16 mm | In distribution |
| LA141211B | Width 14 mm | In distribution |
| LB141212A | Width 14 mm | In distribution |
| LZFSAB08A | Angle 7 ° | In distribution |
| LZFSAB12D | Angle 15 ° | In distribution |
| LZC050000 | In distribution | |
| LZA930000-19 | Angle 15 ° | In distribution |
| LZA970000-10 | Angle 7 ° | In distribution |
| LZFSAA06D | Width 14 mm | In distribution |
| LZFMBB12C | Width 16 mm | In distribution |
| LZFMBC12B | Width 16 mm | In distribution |
| LB141211B | Width 14 mm | In distribution |
| LB161409C | Width 16 mm | In distribution |
| LZA930000-17 | Angle 13 ° | In distribution |
| LZFMBC07C | Width 16 mm | In distribution |
| LA181512B | Width 18 mm | In distribution |
| LB161405C | Width 16 mm | In distribution |
| LZFMBB11D | Width 16 mm | In distribution |
| LZFSBA11C | Angle 13 ° | In distribution |
| LZA930000-37 | Angle 13 ° | In distribution |
| LDD000005 | Height 5 mm | In distribution |
| LZA930000-40 | Angle 15 ° | In distribution |
| LZFSAB07A | Angle 7 ° | In distribution |
| LZFSBB10D | Angle 15 ° | In distribution |
| LA181506B | Width 18 mm | In distribution |
| LZFSAC05C | Angle 13 ° | In distribution |
| LZFMBB07D | Width 16 mm | In distribution |
| LA161411A | Width 16 mm | In distribution |
| LZA930000-51 | Angle 7 ° | In distribution |
| LA141205D | Width 14 mm | In distribution |
| LA181505C | Width 18 mm | In distribution |
| LZFSBB05A | Angle 7 ° | In distribution |
| LZA930000-52 | Angle 7 ° | In distribution |
| LZFSBB10C | Angle 13 ° | In distribution |
| LZFMBC08D | Width 16 mm | In distribution |
| LZFSBB09D | Angle 15 ° | In distribution |
| LB141210B | Width 14 mm | In distribution |
| LZA930000-53 | Angle 10 ° | In distribution |
| LZFMBC05B | Width 16 mm | In distribution |
| LZA960000-20 | In distribution | |
| LZFSAA08B | Width 14 mm | In distribution |
| LB161406D | Width 16 mm | In distribution |
| LZFLBC10C | Width 18 mm | In distribution |
| LZFLBB10C | Width 18 mm | In distribution |
| LZFMBB07C | Width 16 mm | In distribution |
| LB141205A | Width 14 mm | In distribution |
| LZFMBC11B | Width 16 mm | In distribution |
| LA161410A | Width 16 mm | In distribution |
| LZA970000-11 | Angle 7 ° | In distribution |
| LA181511A | Width 18 mm | In distribution |
| LZFSAA08C | Width 14 mm | In distribution |
| LA161408B | Width 16 mm | In distribution |
| LA181512C | Width 18 mm | In distribution |
| LA181508C | Width 18 mm | In distribution |
| LA141206A | Width 14 mm | In distribution |
| LZA930000-21 | Angle 15 ° | In distribution |
| LDD000007 | Height 7 mm | In distribution |
| LZFMBC11C | Width 16 mm | In distribution |
| LA161411D | Width 16 mm | In distribution |
| LZA970000-20 | Angle 10 ° | In distribution |
| LZA030008 | Length 8 mm | In distribution |
| LA141208A | Width 14 mm | In distribution |
| LA181509D | Width 18 mm | In distribution |
| LB141207D | Width 14 mm | In distribution |
| LB141210D | Width 14 mm | In distribution |
| LZFSAC06D | Angle 15 ° | In distribution |
| LB161408C | Width 16 mm | In distribution |
| LB161410A | Width 16 mm | In distribution |
| LZFSAA10B | Angle 10 ° | In distribution |
| LA181505B | Width 18 mm | In distribution |
| LZFMAA09B | Width 16 mm | In distribution |
| LZFLBB11C | Width 18 mm | In distribution |
| LZA930000-20 | Angle 15 ° | In distribution |
| LA161407A | Width 16 mm | In distribution |
| LB141208D | Width 14 mm | In distribution |
| LB141208A | Width 14 mm | In distribution |
| LB161406C | Width 16 mm | In distribution |
| LA141208D | Width 14 mm | In distribution |
| LZA970000-62 | Angle 10 ° | In distribution |
| LZA970000-31 | Angle 13 ° | In distribution |
| LZFSAB09A | Angle 7 ° | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
| A-Cift | Spinefrontier, Inc. | 254 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202065 | 2020-10-26 |
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.