Novel Spinal Spacer System
Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 19 mm
3manufacturers in China registered for this device type
340catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K080699 |
| Record published | 2015-08-31 |
| Record revised | 2020-02-24 (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 | Length 14 to 38 mm; width 8 to 30 mm; height 6 to 50 mm; angle 5 to 12 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64415-220 | Angle 7 ° | In distribution |
| 64313-116 | Width 20 mm | In distribution |
| 64117-014 | Height 12 mm | In distribution |
| 64351-048 | Height 48 mm | In distribution |
| 64835-010 | Width 11 mm | In distribution |
| 64118-006 | Width 10 mm | In distribution |
| 64313-220 | Angle 8 ° | In distribution |
| 64333-324 | Height 24 mm | In distribution |
| 64315-408 | Length 38 mm | In distribution |
| 64807-010 | Height 10 mm | In distribution |
| 64353-440 | Height 40 mm | In distribution |
| 64333-224 | Height 24 mm | In distribution |
| 64305-110 | Width 24 mm | In distribution |
| 64415-212 | Angle 7 ° | In distribution |
| 64311-108 | Height 8 mm | In distribution |
| 64511-112 | Angle 5 ° | In distribution |
| 64315-210 | Length 38 mm | In distribution |
| 64353-240 | Width 20 mm | In distribution |
| 64335-038 | Length 38 mm | In distribution |
| 64331-436 | Width 16 mm | In distribution |
| 64415-412 | Height 12 mm | In distribution |
| 64735-030 | Height 30 mm | In distribution |
| 64618-120 | Width 10 mm | In distribution |
| 64315-020 | Length 38 mm | In distribution |
| 64331-028 | Width 16 mm | In distribution |
| 64311-014 | Length 26 mm | In distribution |
| 64351-046 | Length 26 mm | In distribution |
| 64515-108 | Width 17 mm | In distribution |
| 64117-114 | Angle 5 ° | In distribution |
| 64313-112 | Length 32 mm | In distribution |
| 64311-412 | Width 16 mm | In distribution |
| 64331-324 | Width 16 mm | In distribution |
| 64355-348 | Height 48 mm | In distribution |
| 64315-114 | Width 24 mm | In distribution |
| 64333-028 | Height 28 mm | In distribution |
| 64333-026 | Width 20 mm | In distribution |
| 64353-348 | Height 48 mm | In distribution |
| 64515-110 | Angle 5 ° | In distribution |
| 64117-108 | Width 10 mm | In distribution |
| 64515-114 | Length 34 mm | In distribution |
| 64355-440 | Angle 12 ° | In distribution |
| 64117-012 | Width 10 mm | In distribution |
| 64331-330 | Length 26 mm | In distribution |
| 64313-212 | Length 32 mm | In distribution |
| 64335-034 | Width 24 mm | In distribution |
| 64331-228 | Length 26 mm | In distribution |
| 64335-434 | Length 38 mm | In distribution |
| 64313-244 | Angle 8 ° | In distribution |
| 64313-310 | Width 20 mm | In distribution |
| 64415-218 | Height 18 mm | In distribution |
| 64737-029 | Width 18 mm | In distribution |
| 64331-226 | Length 26 mm | In distribution |
| 64335-328 | Height 28 mm | In distribution |
| 64118-106 | Length 25 mm | In distribution |
| 64833-019 | Length 22 mm | In distribution |
| 64313-010 | Height 10 mm | In distribution |
| 64511-114 | Length 26 mm | In distribution |
| 64311-320 | Angle 10 ° | In distribution |
| 64313-110 | Width 20 mm | In distribution |
| 64835-012 | Length 25 mm | In distribution |
| 64411-116 | Length 28 mm | In distribution |
| 64817-016 | Height 16 mm | In distribution |
| 64355-148 | Length 38 mm | In distribution |
| 64618-118 | Length 25 mm | In distribution |
| 64351-050 | Width 16 mm | In distribution |
| 64315-012 | Width 24 mm | In distribution |
| 64335-024 | Width 24 mm | In distribution |
| 64335-428 | Angle 12 ° | In distribution |
| 64411-418 | Angle 12 ° | In distribution |
| 64805-011 | Width 9 mm | In distribution |
| 64333-134 | Angle 5 ° | In distribution |
| 64713-112 | Width 12 mm | In distribution |
| 64313-418 | Height 18 mm | In distribution |
| 64313-412 | Width 20 mm | In distribution |
| 64331-430 | Length 26 mm | In distribution |
| 64311-122 | Height 22 mm | In distribution |
| 64335-032 | Width 24 mm | In distribution |
| 64335-030 | Length 38 mm | In distribution |
| 64413-118 | Height 18 mm | In distribution |
| 64735-027 | Length 17 mm | In distribution |
| 64315-112 | Length 38 mm | In distribution |
| 64411-208 | Length 26 mm | In distribution |
| 64817-019 | Width 9 mm | In distribution |
| 64511-008 | Length 26 mm | In distribution |
| 64313-020 | Length 32 mm | In distribution |
| 64117-006 | Width 10 mm | In distribution |
| 64413-114 | Width 26 mm | In distribution |
| 64753-149 | Angle 5 ° | In distribution |
| 64353-442 | Length 32 mm | In distribution |
| 64413-108 | Angle 5 ° | In distribution |
| 64331-128 | Length 26 mm | In distribution |
| 64331-438 | Height 38 mm | In distribution |
| 64411-412 | Angle 12 ° | In distribution |
| 64353-344 | Length 32 mm | In distribution |
| 64315-014 | Length 38 mm | In distribution |
| 64315-322 | Length 38 mm | In distribution |
| 64313-118 | Angle 5 ° | In distribution |
| 64353-446 | Length 32 mm | In distribution |
| 64813-020 | Width 9 mm | In distribution |
| 64313-318 | Angle 10 ° | In distribution |
| 64351-348 | Height 48 mm | In distribution |
| 64411-416 | Length 26 mm | In distribution |
| 64117-008 | Length 20 mm | In distribution |
| 64355-140 | Width 24 mm | In distribution |
| 64618-020 | Angle 5 ° | In distribution |
| 64118-108 | Length 25 mm | In distribution |
| 64315-108 | Angle 5 ° | In distribution |
| 64333-230 | Length 32 mm | In distribution |
| 64757-141 | Width 18 mm | In distribution |
| 64355-150 | Width 24 mm | In distribution |
| 64311-020 | Length 26 mm | In distribution |
| 64311-414 | Angle 12 ° | In distribution |
| 64513-014 | Height 14 mm | In distribution |
| 64333-334 | Angle 10 ° | In distribution |
| 64313-408 | Width 20 mm | In distribution |
| 64311-222 | Width 16 mm | In distribution |
| 64335-332 | Width 24 mm | In distribution |
| 64311-216 | Height 16 mm | In distribution |
| 64757-149 | Height 49 mm | In distribution |
| 64333-328 | Length 32 mm | In distribution |
| 64311-420 | Angle 12 ° | In distribution |
| 64335-132 | Height 32 mm | In distribution |
| 64835-008 | Height 8 mm | In distribution |
| 64331-038 | Height 38 mm | In distribution |
| 64515-012 | Height 12 mm | In distribution |
| 64351-440 | Width 16 mm | In distribution |
| 64813-008 | Height 8 mm | In distribution |
| 64313-014 | Height 14 mm | In distribution |
| 64313-012 | Width 20 mm | In distribution |
| 64333-130 | Length 32 mm | In distribution |
| 64411-420 | Width 23 mm | In distribution |
| 64313-208 | Width 20 mm | In distribution |
| 64118-014 | Height 14 mm | In distribution |
| 64817-020 | Length 28 mm | In distribution |
| 64117-107 | Length 20 mm | In distribution |
| 64315-110 | Length 38 mm | In distribution |
| 64313-314 | Length 32 mm | In distribution |
| 64837-016 | Width 11 mm | In distribution |
| 64351-246 | Angle 8 ° | In distribution |
| 64511-012 | Length 26 mm | In distribution |
| 64311-408 | Length 26 mm | In distribution |
| 64351-250 | Width 16 mm | In distribution |
| 64331-234 | Length 26 mm | In distribution |
| 64335-226 | Width 24 mm | In distribution |
| 64353-346 | Width 20 mm | In distribution |
| 64413-112 | Angle 5 ° | In distribution |
| 64335-134 | Length 38 mm | In distribution |
| 64355-044 | Width 24 mm | In distribution |
| 64335-432 | Angle 12 ° | In distribution |
| 64335-026 | Height 26 mm | In distribution |
| 64513-114 | Height 14 mm | In distribution |
| 64618-019 | Angle 5 ° | In distribution |
| 64415-416 | Height 16 mm | In distribution |
| 64335-228 | Angle 8 ° | In distribution |
| 64813-013 | Width 9 mm | In distribution |
| 64311-010 | Height 10 mm | In distribution |
| 64311-110 | Length 26 mm | In distribution |
| 64415-210 | Height 10 mm | In distribution |
| 64355-248 | Height 48 mm | In distribution |
| 64333-136 | Angle 5 ° | In distribution |
| 64335-036 | Width 24 mm | In distribution |
| 64112-110 | Width 8 mm | In distribution |
| 64118-109 | Angle 5 ° | In distribution |
| 64333-124 | Width 20 mm | In distribution |
| 64313-120 | Angle 5 ° | In distribution |
| 64353-144 | Angle 5 ° | In distribution |
| 64333-332 | Height 32 mm | In distribution |
| 64333-034 | Length 32 mm | In distribution |
| 64515-008 | Width 17 mm | In distribution |
| 64333-238 | Width 20 mm | In distribution |
| 64355-442 | Width 24 mm | In distribution |
| 64413-208 | Width 26 mm | In distribution |
| 64835-013 | Length 25 mm | In distribution |
| 64117-010 | Width 10 mm | In distribution |
| 64833-015 | Width 11 mm | In distribution |
| 64315-212 | Length 38 mm | In distribution |
| 64413-214 | Width 26 mm | In distribution |
| 64733-029 | Height 29 mm | In distribution |
| 64733-124 | Height 24 mm | In distribution |
| 64333-228 | Length 32 mm | In distribution |
| 64311-120 | Angle 5 ° | In distribution |
| 64713-023 | Width 12 mm | In distribution |
| 64817-015 | Height 15 mm | In distribution |
| 64333-032 | Height 32 mm | In distribution |
| 64353-148 | Angle 5 ° | In distribution |
| 64713-022 | Length 14 mm | In distribution |
| 64755-047 | Height 47 mm | In distribution |
| 64815-016 | Length 25 mm | In distribution |
| 64351-450 | Width 16 mm | In distribution |
| 64331-032 | Height 32 mm | In distribution |
| 64833-009 | Length 22 mm | In distribution |
| 64753-046 | Height 46 mm | In distribution |
| 64755-050 | Width 15 mm | In distribution |
| 64311-210 | Height 10 mm | In distribution |
| 64333-024 | Height 24 mm | In distribution |
| 64331-424 | Width 16 mm | In distribution |
| 64351-150 | Height 50 mm | In distribution |
| 64335-224 | Width 24 mm | In distribution |
| 64331-134 | Height 34 mm | In distribution |
| 64813-015 | Width 9 mm | In distribution |
| 64333-038 | Height 38 mm | In distribution |
| 64351-248 | Length 26 mm | In distribution |
| 64415-214 | Angle 7 ° | In distribution |
| 64733-036 | Length 14 mm | In distribution |
| 64315-422 | Width 24 mm | In distribution |
| 64104-112 | Angle 5 ° | In distribution |
| 64315-410 | Height 10 mm | In distribution |
| 64118-009 | Height 9 mm | In distribution |
| 64311-422 | Width 16 mm | In distribution |
| 64335-136 | Length 38 mm | In distribution |
| 64118-012 | Width 10 mm | In distribution |
| 64313-016 | Length 32 mm | In distribution |
| 64515-112 | Height 12 mm | In distribution |
| 64351-350 | Angle 10 ° | In distribution |
| 64405-210 | Angle 7 ° | In distribution |
| 64315-010 | Width 24 mm | In distribution |
| 64333-424 | Width 20 mm | In distribution |
| 64118-114 | Angle 5 ° | In distribution |
| 64351-146 | Length 26 mm | In distribution |
| 64515-010 | Width 17 mm | In distribution |
| 64315-418 | Height 18 mm | In distribution |
| 64315-312 | Width 24 mm | In distribution |
| 64117-106 | Width 10 mm | In distribution |
| 64118-107 | Length 25 mm | In distribution |
| 64116-112 | Height 12 mm | In distribution |
| 64315-314 | Length 38 mm | In distribution |
| 64118-110 | Width 10 mm | In distribution |
| 64353-050 | Width 20 mm | In distribution |
| 64313-308 | Width 20 mm | In distribution |
| 64833-018 | Height 18 mm | In distribution |
| 64313-218 | Angle 8 ° | In distribution |
| 64315-008 | Length 38 mm | In distribution |
| 64511-014 | Length 26 mm | In distribution |
| 64313-222 | Height 22 mm | In distribution |
| 64331-428 | Angle 12 ° | In distribution |
| 64117-109 | Angle 5 ° | In distribution |
| 64335-424 | Angle 12 ° | In distribution |
| 64331-024 | Width 16 mm | In distribution |
| 64713-111 | Angle 5 ° | In distribution |
| 64735-135 | Length 17 mm | In distribution |
| 64313-414 | Height 14 mm | In distribution |
| 64112-010 | Height 10 mm | In distribution |
| 64351-442 | Length 26 mm | In distribution |
| 64331-326 | Angle 10 ° | In distribution |
| 64717-011 | Width 18 mm | In distribution |
| 64837-010 | Height 10 mm | In distribution |
| 64717-021 | Width 18 mm | In distribution |
| 64513-008 | Width 15 mm | In distribution |
| 64331-236 | Width 16 mm | In distribution |
| 64335-338 | Width 24 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232173 | 2023-10-06 |
| K080699 | 2008-05-21 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Alphatec Spine, Inc. | 510(k) number | 2009-05-13 | Not classified | Process control | Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant. | 37 devices | 2009-11-13 |
| Alphatec Spine, Inc. | 510(k) number | 2007-08-16 | Not classified | Process control | Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the follo | 4 units | 2009-01-12 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-08-16 | Not classified | Process control | Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the follo | 3 units | 2009-01-12 |
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.