Enclave Anterior Spinal System
176 catalogue numbers from 14-530458, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Bone Graft, Lumbar. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
176catalogue numbers in this listing
5510(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 | Biomet Spine, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2015-10-24 |
| Record revised | 2025-01-03 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-530458 | ENCLAVE STRUT 18MM, 12DEG | In distribution |
| 14-530578 | WIDE 40W X 28D | In distribution |
| 14-530553 | ENCLAVE 13 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530450 | ENCLAVE STRUT 10MM, 12DEG | In distribution |
| 14-530538 | ENCLAVE 18 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530512 | ENCLAVE 12 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530535 | ENCLAVE 15 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530575 | ENCLAVE 15 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530433 | ENCLAVE STRUT 13 MM, 6° | In distribution |
| 14-530539 | MEDIUM 34W X 26D | In distribution |
| 14-530479 | NARROW 28W X 24D | In distribution |
| 14-530499 | NARROW 28W X 24D | In distribution |
| 14-530555 | WIDE 40W X 28D | In distribution |
| 14-530471 | NARROW 28W X 24D | In distribution |
| 14-530580 | ENCLAVE 20 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530440 | ENCLAVE STRUT 20 MM, 6° | In distribution |
| 14-530494 | NARROW 28W X 24D | In distribution |
| 14-530513 | ENCLAVE 13 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530533 | ENCLAVE 13 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530571 | ENCLAVE 11 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530500 | NARROW 28W X 24D | In distribution |
| 14-530517 | ENCLAVE 17 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530454 | ENCLAVE STRUT 14 MM, 12° | In distribution |
| 14-530580 | WIDE 40W X 28D | In distribution |
| 14-530579 | WIDE 40W X 28D | In distribution |
| 14-530574 | WIDE 40W X 28D | In distribution |
| 14-530456 | ENCLAVE STRUT 16MM, 12DEG | In distribution |
| 14-530434 | ENCLAVE STRUT 14MM, 6DEG | In distribution |
| 14-530559 | WIDE 40W X 28D | In distribution |
| 14-530519 | MEDIUM 34W X 26D | In distribution |
| 14-530473 | NARROW 28W X 24D | In distribution |
| 14-530459 | ENCLAVE STRUT 19 MM, 12° | In distribution |
| 14-530552 | WIDE 40W X 28D | In distribution |
| 14-530493 | ENCLAVE 13 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530530 | ENCLAVE 10 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530533 | MEDIUM 34W X 26D | In distribution |
| 14-530510 | MEDIUM 34W X 26D | In distribution |
| 14-530552 | ENCLAVE 12 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530554 | ENCLAVE 14 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530457 | ENCLAVE STRUT 17MM, 12DEG | In distribution |
| 14-530497 | NARROW 28W X 24D | In distribution |
| 14-530520 | MEDIUM 34W X 26D | In distribution |
| 14-530538 | MEDIUM 34W X 26D | In distribution |
| 14-530439 | ENCLAVE STRUT 19MM, 6DEG | In distribution |
| 14-530453 | ENCLAVE STRUT 13 MM, 12° | In distribution |
| 14-530514 | ENCLAVE 14 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530539 | ENCLAVE 19 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530432 | ENCLAVE STRUT 12 MM, 6° | In distribution |
| 14-530480 | NARROW 28W X 24D | In distribution |
| 14-530551 | ENCLAVE 11 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530471 | ENCLAVE 11 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530460 | ENCLAVE STRUT 20 MM, 12° | In distribution |
| 14-530472 | ENCLAVE 12 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530436 | ENCLAVE STRUT 16 MM, 6° | In distribution |
| 14-530516 | ENCLAVE 16 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530557 | WIDE 40W X 28D | In distribution |
| 14-530532 | MEDIUM 34W X 26D | In distribution |
| 14-530558 | WIDE 40W X 28D | In distribution |
| 14-530537 | ENCLAVE 17 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530559 | ENCLAVE 19 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530430 | ENCLAVE STRUT 10MM, 6DEG | In distribution |
| 14-530459 | ENCLAVE STRUT 19MM, 12DEG | In distribution |
| 14-530493 | NARROW 28W X 24D | In distribution |
| 14-530492 | NARROW 28W X 24D | In distribution |
| 14-530435 | ENCLAVE STRUT 15 MM, 6° | In distribution |
| 14-530477 | ENCLAVE 17 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530514 | MEDIUM 34W X 26D | In distribution |
| 14-530477 | NARROW 28W X 24D | In distribution |
| 14-530572 | WIDE 40W X 28D | In distribution |
| 14-530557 | ENCLAVE 17 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530531 | MEDIUM 34W X 26D | In distribution |
| 14-530511 | ENCLAVE 11 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530454 | ENCLAVE STRUT 14MM, 12DEG | In distribution |
| 14-530474 | NARROW 28W X 24D | In distribution |
| 14-530500 | ENCLAVE 20 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530516 | MEDIUM 34W X 26D | In distribution |
| 14-530519 | ENCLAVE 19 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530532 | ENCLAVE 12 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530515 | ENCLAVE 15 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530432 | ENCLAVE STRUT 12MM, 6DEG | In distribution |
| 14-530540 | ENCLAVE 20 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530576 | WIDE 40W X 28D | In distribution |
| 14-530491 | NARROW 28W X 24D | In distribution |
| 14-530433 | ENCLAVE STRUT 13MM, 6DEG | In distribution |
| 14-530470 | ENCLAVE 10 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530498 | NARROW 28W X 24D | In distribution |
| 14-530492 | ENCLAVE 12 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530518 | MEDIUM 34W X 26D | In distribution |
| 14-530550 | WIDE 40W X 28D | In distribution |
| 14-530577 | ENCLAVE 17 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530479 | ENCLAVE 19 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530476 | NARROW 28W X 24D | In distribution |
| 14-530513 | MEDIUM 34W X 26D | In distribution |
| 14-530430 | ENCLAVE STRUT 10 MM, 6° | In distribution |
| 14-530573 | WIDE 40W X 28D | In distribution |
| 14-530556 | WIDE 40W X 28D | In distribution |
| 14-530495 | NARROW 28W X 24D | In distribution |
| 14-530480 | ENCLAVE 20 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530556 | ENCLAVE 16 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530578 | ENCLAVE 18 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530520 | ENCLAVE 20 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530473 | ENCLAVE 13 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530499 | ENCLAVE 19 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530572 | ENCLAVE 12 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530475 | ENCLAVE 15 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530435 | ENCLAVE STRUT 15MM, 6DEG | In distribution |
| 14-530534 | MEDIUM 34W X 26D | In distribution |
| 14-530437 | ENCLAVE STRUT 17MM, 6DEG | In distribution |
| 14-530573 | ENCLAVE 13 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530553 | WIDE 40W X 28D | In distribution |
| 14-530576 | ENCLAVE 16 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530495 | ENCLAVE 15 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530438 | ENCLAVE STRUT 18MM, 6DEG | In distribution |
| 14-530574 | ENCLAVE 14 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530431 | ENCLAVE STRUT 11MM, 6DEG | In distribution |
| 14-530515 | MEDIUM 34W X 26D | In distribution |
| 14-530550 | ENCLAVE 10 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530431 | ENCLAVE STRUT 11 MM, 6° | In distribution |
| 14-530560 | ENCLAVE 20 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530558 | ENCLAVE 18 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530498 | ENCLAVE 18 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530560 | WIDE 40W X 28D | In distribution |
| 14-530496 | ENCLAVE 16 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530575 | WIDE 40W X 28D | In distribution |
| 14-530518 | ENCLAVE 18 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530452 | ENCLAVE STRUT 12 MM, 12° | In distribution |
| 14-530535 | MEDIUM 34W X 26D | In distribution |
| 14-530491 | ENCLAVE 11 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530497 | ENCLAVE 17 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530536 | ENCLAVE 16 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530455 | ENCLAVE STRUT 15MM, 12DEG | In distribution |
| 14-530458 | ENCLAVE STRUT 18 MM, 12° | In distribution |
| 14-530472 | NARROW 28W X 24D | In distribution |
| 14-530476 | ENCLAVE 16 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530490 | NARROW 28W X 24D | In distribution |
| 14-530571 | WIDE 40W X 28D | In distribution |
| 14-530450 | ENCLAVE STRUT 10 MM, 12° | In distribution |
| 14-530438 | ENCLAVE STRUT 18 MM, 6° | In distribution |
| 14-530436 | ENCLAVE STRUT 16MM, 6DEG | In distribution |
| 14-530460 | ENCLAVE STRUT 20MM, 12DEG | In distribution |
| 14-530440 | ENCLAVE STRUT 20MM, 6DEG | In distribution |
| 14-530494 | ENCLAVE 14 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530439 | ENCLAVE STRUT 19 MM, 6° | In distribution |
| 14-530512 | MEDIUM 34W X 26D | In distribution |
| 14-530537 | MEDIUM 34W X 26D | In distribution |
| 14-530451 | ENCLAVE STRUT 11 MM, 12° | In distribution |
| 14-530452 | ENCLAVE STRUT 12MM, 12DEG | In distribution |
| 14-530478 | NARROW 28W X 24D | In distribution |
| 14-530434 | ENCLAVE STRUT 14 MM, 6° | In distribution |
| 14-530496 | NARROW 28W X 24D | In distribution |
| 14-530534 | ENCLAVE 14 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530540 | MEDIUM 34W X 26D | In distribution |
| 14-530453 | ENCLAVE STRUT 13MM, 12DEG | In distribution |
| 14-530457 | ENCLAVE STRUT 17 MM, 12° | In distribution |
| 14-530474 | ENCLAVE 14 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530455 | ENCLAVE STRUT 15 MM, 12° | In distribution |
| 14-530478 | ENCLAVE 18 MM, 6° NARROW 28W X 24D | In distribution |
| 14-530530 | MEDIUM 34W X 26D | In distribution |
| 14-530570 | WIDE 40W X 28D | In distribution |
| 14-530551 | WIDE 40W X 28D | In distribution |
| 14-530511 | MEDIUM 34W X 26D | In distribution |
| 14-530536 | MEDIUM 34W X 26D | In distribution |
| 14-530456 | ENCLAVE STRUT 16 MM, 12° | In distribution |
| 14-530451 | ENCLAVE STRUT 11MM, 12DEG | In distribution |
| 14-530470 | NARROW 28W X 24D | In distribution |
| 14-530570 | ENCLAVE 10 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530510 | ENCLAVE 10 MM, 6° MEDIUM 34W X 26D | In distribution |
| 14-530554 | WIDE 40W X 28D | In distribution |
| 14-530555 | ENCLAVE 15 MM, 6° WIDE 40W X 28D | In distribution |
| 14-530531 | ENCLAVE 11 MM, 12° MEDIUM 34W X 26D | In distribution |
| 14-530475 | NARROW 28W X 24D | In distribution |
| 14-530490 | ENCLAVE 10 MM, 12° NARROW 28W X 24D | In distribution |
| 14-530577 | WIDE 40W X 28D | In distribution |
| 14-530517 | MEDIUM 34W X 26D | In distribution |
| 14-530579 | ENCLAVE 19 MM, 12° WIDE 40W X 28D | In distribution |
| 14-530437 | ENCLAVE STRUT 17 MM, 6° | In distribution |
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 |
|---|---|
| K153695 | 2016-01-21 |
| K151483 | 2015-07-31 |
| K142634 | 2015-03-12 |
| K112014 | 2011-10-17 |
| K081636 | 2008-08-07 |
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.