Crescent™ Spinal System
Spacer 9393012 Crescnt Spnal Systm 30X12
14manufacturers in China registered for this device type
122catalogue numbers in this listing
18510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K110543 |
| Record published | 2015-08-21 |
| Record revised | 2024-09-11 (version 7) |
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 |
| Sizes | Length 12 to 45 mm; height 7 to 36 mm; width 10 to 24 mm; angle 6 ° |
| Distribution end date | 2026-01-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6660825 | Height 8.0 mm | In distribution |
| 7969812 | Height 30.0 mm | In distribution |
| 6661330 | Length 30.0 mm | In distribution |
| 9393012 | In distribution | |
| 6661225 | Height 12.0 mm | In distribution |
| 6661525 | Height 15.0 mm | In distribution |
| 6661325 | Length 25.0 mm | In distribution |
| 9393008 | In distribution | |
| 7968818 | Height 27.0 mm | In distribution |
| X0515004 | Height 10.0 mm | In distribution |
| 9392513 | In distribution | |
| 9392507 | In distribution | |
| 6671230 | Width 12.0 mm | In distribution |
| 6671336 | Length 13.0 mm | In distribution |
| 9393015 | In distribution | |
| 9393009 | In distribution | |
| 7969222 | Height 30.0 mm | In distribution |
| 7969210 | Width 10.0 mm | In distribution |
| 7968816 | Length 16.0 mm | In distribution |
| 9393007 | In distribution | |
| 9393613 | In distribution | |
| 7968224 | Width 24.0 mm | In distribution |
| X0515003 | Height 9.0 mm | In distribution |
| X0515006 | Height 12.0 mm | In distribution |
| 9393010 | In distribution | |
| 6661636 | Width 10.0 mm | In distribution |
| 6661536 | Height 15.0 mm | In distribution |
| 7969220 | Width 20.0 mm | In distribution |
| 7968222 | Height 27.0 mm | In distribution |
| 7969818 | Width 18.0 mm | In distribution |
| X0515008 | Height 14.0 mm | In distribution |
| X0515002 | Length 45.0 mm | In distribution |
| 6660000 | In distribution | |
| 6661230 | Height 12.0 mm | In distribution |
| 7968820 | Length 37.0 mm | In distribution |
| 6661236 | Length 36.0 mm | In distribution |
| X0515010 | Length 40.0 mm | In distribution |
| 9393609 | In distribution | |
| 9392509 | In distribution | |
| 9393014 | In distribution | |
| 6671236 | Length 12.0 mm | In distribution |
| 7968220 | Length 37.0 mm | In distribution |
| 6661125 | Height 11.0 mm | In distribution |
| 6671330 | Angle 6.0 ° | In distribution |
| 7968814 | Length 37.0 mm | In distribution |
| 6661030 | Height 10.0 mm | In distribution |
| 6661430 | Width 10.0 mm | In distribution |
| 6660730 | Height 7.0 mm | In distribution |
| 9392514 | In distribution | |
| 6660936 | Height 9.0 mm | In distribution |
| 7968218 | Width 18.0 mm | In distribution |
| 6671436 | Angle 6.0 ° | In distribution |
| 9393607 | In distribution | |
| 7969824 | Length 42.0 mm | In distribution |
| 6661136 | Height 11.0 mm | In distribution |
| X0515007 | Length 45.0 mm | In distribution |
| 9392511 | In distribution | |
| X0912057 | In distribution | |
| 7969224 | Length 42.0 mm | In distribution |
| 7969216 | Length 42.0 mm | In distribution |
| 6671536 | Height 36.0 mm | In distribution |
| 7969822 | Length 42.0 mm | In distribution |
| X0515005 | Height 11.0 mm | In distribution |
| X0515009 | Height 15.0 mm | In distribution |
| 6661036 | In distribution | |
| 9393610 | In distribution | |
| 9393013 | In distribution | |
| 9393608 | In distribution | |
| X0415016 | Length 40.0 mm | In distribution |
| 9392515 | In distribution | |
| 7969814 | Width 14.0 mm | In distribution |
| 9392508 | In distribution | |
| 6660930 | Length 30.0 mm | In distribution |
| 6660836 | Height 8.0 mm | In distribution |
| 6661530 | Length 30.0 mm | In distribution |
| 6661630 | Angle 6.0 ° | In distribution |
| 6661625 | Length 16.0 mm | In distribution |
| 9393615 | In distribution | |
| 7969218 | Height 30.0 mm | In distribution |
| X0415013 | Height 10.0 mm | In distribution |
| 6671630 | Length 16.0 mm | In distribution |
| 9393011 | In distribution | |
| 7968810 | Height 27.0 mm | In distribution |
| 7968812 | Length 37.0 mm | In distribution |
| 6661436 | Length 36.0 mm | In distribution |
| 9393614 | In distribution | |
| 7969816 | Height 30.0 mm | In distribution |
| 9392512 | In distribution | |
| 6661425 | Height 14.0 mm | In distribution |
| 6661130 | Height 11.0 mm | In distribution |
| 7969212 | Height 30.0 mm | In distribution |
| X0415015 | Height 12.0 mm | In distribution |
| 6660736 | Length 36.0 mm | In distribution |
| 7968824 | Width 24.0 mm | In distribution |
| 9393612 | In distribution | |
| 7969214 | Width 14.0 mm | In distribution |
| 7969820 | Length 42.0 mm | In distribution |
| 9393611 | In distribution | |
| X0415012 | Length 40.0 mm | In distribution |
| X0515001 | Length 45.0 mm | In distribution |
| X0515019 | Length 45.0 mm | In distribution |
| 9392510 | In distribution | |
| X0415018 | Height 15.0 mm | In distribution |
| 7968212 | Height 27.0 mm | In distribution |
| 6660925 | Height 9.0 mm | In distribution |
| 6661025 | Height 10.0 mm | In distribution |
| 7969810 | Width 10.0 mm | In distribution |
| 7968210 | Length 37.0 mm | In distribution |
| 6661336 | Length 36.0 mm | In distribution |
| 6671530 | Width 12.0 mm | In distribution |
| 7968822 | Length 37.0 mm | In distribution |
| X0415014 | Height 11.0 mm | In distribution |
| 6671430 | Length 14.0 mm | In distribution |
| X0415011 | Length 40.0 mm | In distribution |
| X0415010 | Height 7.0 mm | In distribution |
| 6660725 | Height 7.0 mm | In distribution |
| 7968216 | Width 16.0 mm | In distribution |
| 7968214 | Length 37.0 mm | In distribution |
| 6660830 | Length 30.0 mm | In distribution |
| 6671636 | Height 36.0 mm | In distribution |
| X0415017 | Length 40.0 mm | In distribution |
| X0912056 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201267 | 2020-08-26 |
| K172199 | 2017-09-19 |
| K171031 | 2017-07-06 |
| K171468 | 2017-06-13 |
| K132897 | 2013-12-11 |
| K133216 | 2013-11-22 |
| K132700 | 2013-09-26 |
| K123027 | 2013-07-25 |
| K122037 | 2013-03-22 |
| K122591 | 2012-09-18 |
| K111525 | 2011-08-24 |
| K103731 | 2011-07-18 |
| K100175 | 2010-06-02 |
| K094025 | 2010-04-26 |
| K090353 | 2009-09-29 |
| K083026 | 2008-12-29 |
| K082342 | 2008-09-12 |
| K080083 | 2008-04-10 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.