Prospace®
Prospace Peek Implant 5° 13X10.5X22MM
14manufacturers in China registered for this device type
124catalogue numbers in this listing
1recall
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2025-11-13 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SN090P | Length : 26.000 MM | Withdrawn |
| SN041P | Length : 22.000 MM | Withdrawn |
| SN122P | Length : 26.000 MM | Withdrawn |
| SN143P | Length : 22.000 MM | Withdrawn |
| SN037P | Length : 22.000 MM | Withdrawn |
| SN110P | Length : 22.000 MM | Withdrawn |
| SN112P | Length : 22.000 MM | Withdrawn |
| SN184P | Length : 26.000 MM | Withdrawn |
| SN024P | Length : 26.000 MM | Withdrawn |
| SN125P | Length : 26.000 MM | Withdrawn |
| SN073P | Length : 22.000 MM | Withdrawn |
| SN130P | Length : 26.000 MM | Withdrawn |
| SN157P | Length : 26.000 MM | Withdrawn |
| SJ234P | Length : 22.000 MM | Withdrawn |
| SN068P | Length : 22.000 MM | Withdrawn |
| SN085P | Length : 26.000 MM | Withdrawn |
| SJ289P | Length : 25.000 MM | Withdrawn |
| SN052P | Length : 26.000 MM | Withdrawn |
| SN128P | Length : 26.000 MM | Withdrawn |
| SN173P | Length : 22.000 MM | Withdrawn |
| SN015P | Degree (°) : 0.000 DEG | Withdrawn |
| SJ239P | Length : 25.000 MM | Withdrawn |
| SJ286P | Degree (°) : 8.000 DEG | Withdrawn |
| SJ252P | Length : 19.000 MM | Withdrawn |
| SN169P | Length : 22.000 MM | Withdrawn |
| SN175P | Length : 22.000 MM | Withdrawn |
| SN168P | Length : 22.000 MM | Withdrawn |
| SN187P | Length : 26.000 MM | Withdrawn |
| SN145P | Length : 22.000 MM | Withdrawn |
| SN010P | Length : 22.000 MM | Withdrawn |
| SJ235P | Length : 22.000 MM | Withdrawn |
| SN162P | Length : 26.000 MM | Withdrawn |
| SN138P | Length : 22.000 MM | Withdrawn |
| SN127P | Length : 26.000 MM | Withdrawn |
| SJ259P | Length : 25.000 MM | Withdrawn |
| SN156P | Height : 11.000 MM | Withdrawn |
| SJ233P | Length : 19.000 MM | Withdrawn |
| SN171P | Length : 22.000 MM | Withdrawn |
| SN039P | Length : 22.000 MM | Withdrawn |
| SN092P | Length : 26.000 MM | Withdrawn |
| SN123P | Length : 26.000 MM | Withdrawn |
| SN083P | Length : 26.000 MM | Withdrawn |
| SN192P | Length : 26.000 MM | Withdrawn |
| SN057P | Length : 26.000 MM | Withdrawn |
| SN075P | Length : 22.000 MM | Withdrawn |
| SN017P | Length : 22.000 MM | Withdrawn |
| SN071P | Length : 22.000 MM | Withdrawn |
| SN140P | Length : 22.000 MM | Withdrawn |
| SN141P | Length : 22.000 MM | Withdrawn |
| SN087P | Length : 26.000 MM | Withdrawn |
| SN038P | Length : 22.000 MM | Withdrawn |
| SN158P | Length : 26.000 MM | Withdrawn |
| SN177P | Length : 22.000 MM | Withdrawn |
| SN011P | Length : 22.000 MM | Withdrawn |
| SN107P | Length : 22.000 MM | Withdrawn |
| SN160P | Length : 26.000 MM | Withdrawn |
| SN028P | Length : 26.000 MM | Withdrawn |
| SN117P | Length : 22.000 MM | Withdrawn |
| SJ238P | Length : 25.000 MM | Withdrawn |
| SN027P | Length : 26.000 MM | Withdrawn |
| SN026P | Length : 26.000 MM | Withdrawn |
| SN172P | Length : 22.000 MM | Withdrawn |
| SN088P | Length : 26.000 MM | Withdrawn |
| SN013P | Length : 22.000 MM | Withdrawn |
| SJ283P | Length : 19.000 MM | Withdrawn |
| SN142P | Length : 22.000 MM | Withdrawn |
| SN111P | Length : 22.000 MM | Withdrawn |
| SN009P | Length : 22.000 MM | Withdrawn |
| SN170P | Length : 22.000 MM | Withdrawn |
| SN025P | Length : 26.000 MM | Withdrawn |
| SN126P | Length : 26.000 MM | Withdrawn |
| SN070P | Length : 22.000 MM | Withdrawn |
| SN053P | Length : 26.000 MM | Withdrawn |
| SN183P | Length : 26.000 MM | Withdrawn |
| SN007P | Length : 22.000 MM | Withdrawn |
| SN047P | Length : 22.000 MM | Withdrawn |
| SN109P | Length : 22.000 MM | Withdrawn |
| SN115P | Length : 22.000 MM | Withdrawn |
| SJ256P | Length : 22.000 MM | Withdrawn |
| SN022P | Length : 26.000 MM | Withdrawn |
| SN154P | Length : 26.000 MM | Withdrawn |
| SN056P | Length : 26.000 MM | Withdrawn |
| SN072P | Length : 22.000 MM | Withdrawn |
| SN032P | Length : 26.000 MM | Withdrawn |
| SN030P | Length : 26.000 MM | Withdrawn |
| SN062P | Length : 26.000 MM | Withdrawn |
| SN132P | Length : 26.000 MM | Withdrawn |
| SN147P | Length : 22.000 MM | Withdrawn |
| SN108P | Length : 22.000 MM | Withdrawn |
| SJ255P | Length : 22.000 MM | Withdrawn |
| SN042P | Length : 22.000 MM | Withdrawn |
| SN155P | Length : 26.000 MM | Withdrawn |
| SN086P | Length : 26.000 MM | Withdrawn |
| SN055P | Length : 26.000 MM | Withdrawn |
| SN054P | Length : 26.000 MM | Withdrawn |
| SN069P | Length : 22.000 MM | Withdrawn |
| SJ254P | Length : 22.000 MM | Withdrawn |
| SN084P | Length : 26.000 MM | Withdrawn |
| SJ232P | Length : 19.000 MM | Withdrawn |
| SN186P | Length : 26.000 MM | Withdrawn |
| SN008P | Length : 22.000 MM | Withdrawn |
| SN043P | Length : 22.000 MM | Withdrawn |
| SN137P | Length : 22.000 MM | Withdrawn |
| SJ288P | Length : 25.000 MM | Withdrawn |
| SN060P | Length : 26.000 MM | Withdrawn |
| SN124P | Length : 26.000 MM | Withdrawn |
| SJ258P | Length : 25.000 MM | Withdrawn |
| SN139P | Length : 22.000 MM | Withdrawn |
| SN185P | Length : 26.000 MM | Withdrawn |
| SJ285P | Length : 22.000 MM | Withdrawn |
| SN045P | Length : 22.000 MM | Withdrawn |
| SN190P | Length : 26.000 MM | Withdrawn |
| SN058P | Length : 26.000 MM | Withdrawn |
| SJ253P | Length : 19.000 MM | Withdrawn |
| SN040P | Length : 22.000 MM | Withdrawn |
| SN113P | Length : 22.000 MM | Withdrawn |
| SN077P | Length : 22.000 MM | Withdrawn |
| SJ236P | Length : 22.000 MM | Withdrawn |
| SN152P | Length : 26.000 MM | Withdrawn |
| SJ282P | Length : 19.000 MM | Withdrawn |
| SN012P | Length : 22.000 MM | Withdrawn |
| SN188P | Length : 26.000 MM | Withdrawn |
| SN153P | Length : 26.000 MM | Withdrawn |
| SN023P | Length : 26.000 MM | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-06-18 | Class II | Employee error | Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant – 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. The device is labe | 9 | 2014-01-13 |
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.