Solitaire-C Cervical Spacer

256 catalogue numbers from 14-520537, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Integrated Fixation, Cervical. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26
5manufacturers in China registered for this device type
256catalogue numbers in this listing
2510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code OVE
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

Regulatory record for Solitaire-C Cervical Spacer
Listed by Biomet Spine, United States
FDA product code OVE
Device type Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Record published 2015-10-24
Record revised 2025-01-03 (version 5)

Specifications

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, expiry date

Catalogue Numbers

Catalogue numbers for Solitaire-C Cervical Spacer
Catalogue number Size Status
14-520537 SOLI-C SPACER 7HX16WX14D-L In distribution
14-520507 Spacer 7H x 14W x 12D-L PEEK Lordotic (7°) In distribution
14-520791 SOLI-C SPACER 11HX18WX15D-P In distribution
14-531727E 3.75 mm x 17 mm Screw In distribution
14-520736 SOLI-C SPACER 6HX16WX14D-P In distribution
14-520790 SOLI-C SPACER 10HX18WX15D-P In distribution
14-531713E 3.5 mm x 13 mm Screw In distribution
14-520610 SOLI-C SPACER 10HX20WX14D-L In distribution
14-520570 Spacer 10H x 18W x 12D-L PEEK Lordotic (7°) In distribution
14-531726E 3.75 mm x 16 mm Screw In distribution
14-520541 SOLI-C SPACER 11HX16WX14D-L In distribution
14-531718E 3.5 mm x 18 mm Screw In distribution
14-520589 Spacer 9H x 18W x 15D-L PEEK Lordotic (7°) In distribution
14-531728E 3.75 mm x 18 mm Screw In distribution
14-520559 Spacer 9H x 16W x 16D-L PEEK Lordotic (7°) In distribution
14-520527 Spacer 7H x 16W x 12D-L PEEK Lordotic (7°) In distribution
14-520531 SOLI-C SPACER 11HX16WX12D-L In distribution
14-520581 Spacer 11H x 18W x 14D-L PEEK Lordotic (7°) In distribution
14-520588 SOLI-C SPACER 8HX18WX15D-L In distribution
14-520609 Spacer 9H x 20W x 14D-L PEEK Lordotic (7°) In distribution
14-520741 SOLI-C SPACER 11HX16WX14D-P In distribution
14-520600 SOLI-C SPACER 10HX18WX16D-L In distribution
14-520520 SOLI-C SPACER 10HX14WX14D-L In distribution
14-520786 Spacer 6H x 18W x 15D-P PEEK Parallel In distribution
14-520547 Spacer 7H x 16W x 15D-L PEEK Lordotic (7°) In distribution
14-520708 SOLI-C SPACER 8HX14WX12D-P In distribution
14-520628 SOLI-C SPACER 8HX20WX16D-L In distribution
14-520556 Spacer 6H x 16W x 16D-L PEEK Lordotic (7°) In distribution
14-520530 Spacer 10H x 16W x 12D-L PEEK Lordotic (7°) In distribution
14-520529 Spacer 9H x 16W x 12D-L PEEK Lordotic (7°) In distribution
14-520787 Spacer 7H x 18W x 15D-P PEEK Parallel In distribution
14-520572 Spacer 12H x 18W x 12D-L PEEK Lordotic (7°) In distribution
14-531716E 3.5 mm x 16 mm Screw In distribution
14-520537 Spacer 7H x 16W x 14D-L PEEK Lordotic (7°) In distribution
14-520548 Spacer 8H x 16W x 15D-L PEEK Lordotic (7°) In distribution
14-520582 SOLI-C SPACER 12HX18WX14D-L In distribution
14-520538 SOLI-C SPACER 8HX16WX14D-L In distribution
14-520578 Spacer 8H x 18W x 14D-L PEEK Lordotic (7°) In distribution
14-520789 Spacer 9H x 18W x 15D-P PEEK Parallel In distribution
14-520571 Spacer 11H x 18W x 12D-L PEEK Lordotic (7°) In distribution
14-520630 Spacer 10H x 20W x 16D-L PEEK Lordotic (7°) In distribution
14-520587 SOLI-C SPACER 7HX18WX15D-L In distribution
14-520579 SOLI-C SPACER 9HX18WX14D-L In distribution
14-520566 SOLI-C SPACER 6HX18WX12D-L In distribution
14-520629 Spacer 9H x 20W x 16D-L PEEK Lordotic (7°) In distribution
14-520517 SOLI-C SPACER 7HX14WX14D-L In distribution
14-520587 Spacer 7H x 18W x 15D-L PEEK Lordotic (7°) In distribution
14-520627 Spacer 7H x 20W x 16D-L PEEK Lordotic (7°) In distribution
14-531714E 3.5 mm x 14 mm Screw In distribution
14-520542 Spacer 12H x 16W x 14D-L PEEK Lordotic (7°) In distribution
14-520740 SOLI-C SPACER 10HX16WX14D-P In distribution
14-520556 SOLI-C SPACER 6HX16WX16D-L In distribution
14-520547 SOLI-C SPACER 7HX16WX15D-L In distribution
14-520620 Spacer 10H x 20W x 15D-L PEEK Lordotic (7°) In distribution
14-520616 Spacer 6H x 20W x 15D-L PEEK Lordotic (7°) In distribution
14-520618 Spacer 8H x 20W x 15D-L PEEK Lordotic (7°) In distribution
14-531727 SOLI-C 3.75X17MM SCREW In distribution
14-520569 SOLI-C SPACER 9HX18WX12D-L In distribution
14-520790 Spacer 10H x 18W x 15D-P PEEK Parallel In distribution
14-520788 SOLI-C SPACER 8HX18WX15D-P In distribution
14-520608 SOLI-C SPACER 8HX20WX14D-L In distribution
14-520592 Spacer 12H x 18W x 15D-L PEEK Lordotic (7°) In distribution
14-520709 SOLI-C SPACER 9HX14WX12D-P In distribution
14-520586 Spacer 6H x 18W x 15D-L PEEK Lordotic (7°) In distribution
14-531711 SOLI-C 3.5X11MM SCREW In distribution
14-520506 Spacer 6H x 14W x 12D-L PEEK Lordotic (7°) In distribution
14-520569 Spacer 9H x 18W x 12D-L PEEK Lordotic (7°) In distribution
14-520789 SOLI-C SPACER 9HX18WX15D-P In distribution
14-520540 Spacer 10H x 16W x 14D-L PEEK Lordotic (7°) In distribution
14-520560 Spacer 10H x 16W x 16D-L PEEK Lordotic (7°) In distribution
14-520606 Spacer 6H x 20W x 14D-L PEEK Lordotic (7°) In distribution
14-520596 Spacer 6H x 18W x 16D-L PEEK Lordotic (7°) In distribution
14-520602 Spacer 12H x 18W x 16D-L PEEK Lordotic (7°) In distribution
14-531725 SOLI-C 3.75X15MM SCREW In distribution
14-520597 Spacer 7H x 18W x 16D-L PEEK Lordotic (7°) In distribution
14-520510 SOLI-C SPACER 10HX14WX12D-L In distribution
14-520529 SOLI-C SPACER 9HX16WX12D-L In distribution
14-520621 Spacer 11H x 20W x 15D-L PEEK Lordotic (7°) In distribution
14-520558 SOLI-C SPACER 8HX16WX16D-L In distribution
14-520608 Spacer 8H x 20W x 14D-L PEEK Lordotic (7°) In distribution
14-520598 SOLI-C SPACER 8HX18WX16D-L In distribution
14-520539 SOLI-C SPACER 9HX16WX14D-L In distribution
14-520707 SOLI-C SPACER 7HX14WX12D-P In distribution
14-520786 SOLI-C SPACER 6HX18WX15D-P In distribution
14-520557 Spacer 7H x 16W x 16D-L PEEK Lordotic (7°) In distribution
14-520632 Spacer 12H x 20W x 16D-L PEEK Lordotic (7°) In distribution
14-520612 SOLI-C SPACER 12HX20WX14D-L In distribution
14-520792 Spacer 12H x 18W x 15D-P PEEK Parallel In distribution
14-520597 SOLI-C SPACER 7HX18WX16D-L In distribution
14-531716 SOLI-C 3.5X16MM SCREW In distribution
14-531717E 3.5 mm x 17 mm Screw In distribution
14-520631 Spacer 11H x 20W x 16D-L PEEK Lordotic (7°) In distribution
14-520590 SOLI-C SPACER 10HX18WX15D-L In distribution
14-520579 Spacer 9H x 18W x 14D-L PEEK Lordotic (7°) In distribution
14-520526 SOLI-C SPACER 6HX16WX12D-L In distribution
14-520536 SOLI-C SPACER 6HX16WX14D-L In distribution
14-520596 SOLI-C SPACER 6HX18WX16D-L In distribution
14-520516 SOLI-C SPACER 6HX14WX14D-L In distribution
14-520557 SOLI-C SPACER 7HX16WX16D-L In distribution
14-520607 SOLI-C SPACER 7HX20WX14D-L In distribution
14-520522 SOLI-C SPACER 12HX14WX14D-L In distribution
14-520711 Spacer 11H x 14W x 12D-P PEEK Parallel In distribution
14-520539 Spacer 9H x 16W x 14D-L PEEK Lordotic (7°) In distribution
14-520550 Spacer 10H x 16W x 15D-L PEEK Lordotic (7°) In distribution
14-520787 SOLI-C SPACER 7HX18WX15D-P In distribution
14-520512 Spacer 12H x 14W x 12D-L PEEK Lordotic (7°) In distribution
14-520542 SOLI-C SPACER 12HX16WX14D-L In distribution
14-520519 SOLI-C SPACER 9HX14WX14D-L In distribution
14-520511 SOLI-C SPACER 11HX14WX12D-L In distribution
14-520518 SOLI-C SPACER 8HX14WX14D-L In distribution
14-520552 SOLI-C SPACER 12HX16WX15D-L In distribution
14-520562 SOLI-C SPACER 12HX16WX16D-L In distribution
14-531722E 3.75 mm x 12 mm Screw In distribution
14-520568 Spacer 8H x 18W x 12D-L PEEK Lordotic (7°) In distribution
14-520627 SOLI-C SPACER 7HX20WX16D-L In distribution
14-520571 SOLI-C SPACER 11HX18WX12D-L In distribution
14-520609 SOLI-C SPACER 9HX20WX14D-L In distribution
14-520552 Spacer 12H x 16W x 15D-L PEEK Lordotic (7°) In distribution
14-520561 SOLI-C SPACER 11HX16WX16D-L In distribution
14-520712 SOLI-C SPACER 12HX14WX12D-P In distribution
14-520577 SOLI-C SPACER 7HX18WX14D-L In distribution
14-520586 SOLI-C SPACER 6HX18WX15D-L In distribution
14-531723E 3.75 mm x 13 mm Screw In distribution
14-520629 SOLI-C SPACER 9HX20WX16D-L In distribution
14-520521 SOLI-C SPACER 11HX14WX14D-L In distribution
14-531723 SOLI-C 3.75X13MM SCREW In distribution
14-520622 SOLI-C SPACER 12HX20WX15D-L In distribution
14-520576 SOLI-C SPACER 6HX18WX14D-L In distribution
14-520600 Spacer 10H x 18W x 16D-L PEEK Lordotic (7°) In distribution
14-520516 Spacer 6H x 14W x 14D-L PEEK Lordotic (7°) In distribution
14-520612 Spacer 12H x 20W x 14D-L PEEK Lordotic (7°) In distribution
14-520517 Spacer 7H x 14W x 14D-L PEEK Lordotic (7°) In distribution
14-520712 Spacer 12H x 14W x 12D-P PEEK Parallel In distribution
14-520591 Spacer 11H x 18W x 15D-L PEEK Lordotic (7°) In distribution
14-520618 SOLI-C SPACER 8HX20WX15D-L In distribution
14-531718 SOLI-C 3.5X18MM SCREW In distribution
14-520540 SOLI-C SPACER 10HX16WX14D-L In distribution
14-520622 Spacer 12H x 20W x 15D-L PEEK Lordotic (7°) In distribution
14-520566 Spacer 6H x 18W x 12D-L PEEK Lordotic (7°) In distribution
14-520610 Spacer 10H x 20W x 14D-L PEEK Lordotic (7°) In distribution
14-520737 SOLI-C SPACER 7HX16WX14D-P In distribution
14-520581 SOLI-C SPACER 11HX18WX14D-L In distribution
14-520561 Spacer 11H x 16W x 16D-L PEEK Lordotic (7°) In distribution
14-531728 SOLI-C 3.75X18MM SCREW In distribution
14-520509 Spacer 9H x 14W x 12D-L PEEK Lordotic (7°) In distribution
14-520601 Spacer 11H x 18W x 16D-L PEEK Lordotic (7°) In distribution
14-520582 Spacer 12H x 18W x 14D-L PEEK Lordotic (7°) In distribution
14-531726 SOLI-C 3.75X16MM SCREW In distribution
14-520541 Spacer 11H x 16W x 14D-L PEEK Lordotic (7°) In distribution
14-520570 SOLI-C SPACER 10HX18WX12D-L In distribution
14-520508 Spacer 8H x 14W x 12D-L PEEK Lordotic (7°) In distribution
14-520536 Spacer 6H x 16W x 14D-L PEEK Lordotic (7°) In distribution
14-520522 Spacer 12H x 14W x 14D-L PEEK Lordotic (7°) In distribution
14-531721 SOLI-C 3.75X11MM SCREW In distribution
14-520611 SOLI-C SPACER 11HX20WX14D-L In distribution
14-531712E 3.5 mm x 12 mm Screw In distribution
14-520512 SOLI-C SPACER 12HX14WX12D-L In distribution
14-531724E 3.75 mm x 14 mm Screw In distribution
14-520528 Spacer 8H x 16W x 12D-L PEEK Lordotic (7°) In distribution
14-520538 Spacer 8H x 16W x 14D-L PEEK Lordotic (7°) In distribution
14-531721E 3.75 mm x 11 mm Screw In distribution
14-520619 SOLI-C SPACER 9HX20WX15D-L In distribution
14-520590 Spacer 10H x 18W x 15D-L PEEK Lordotic (7°) In distribution
14-520706 Spacer 6H x 14W x 12D-P PEEK Parallel In distribution
14-520710 Spacer 10H x 14W x 12D-P PEEK Parallel In distribution
14-520620 SOLI-C SPACER 10HX20WX15D-L In distribution
14-531717 SOLI-C 3.5X17MM SCREW In distribution
14-520741 Spacer 11H x 16W x 14D-P PEEK Parallel In distribution
14-520531 Spacer 11H x 16W x 12D-L PEEK Lordotic (7°) In distribution
14-520706 SOLI-C SPACER 6HX14WX12D-P In distribution
14-520737 Spacer 7H x 16W x 14D-P PEEK Parallel In distribution
14-520617 SOLI-C SPACER 7HX20WX15D-L In distribution
14-520607 Spacer 7H x 20W x 14D-L PEEK Lordotic (7°) In distribution
14-520518 Spacer 8H x 14W x 14D-L PEEK Lordotic (7°) In distribution
14-520736 Spacer 6H x 16W x 14D-P PEEK Parallel In distribution
14-520562 Spacer 12H x 16W x 16D-L PEEK Lordotic (7°) In distribution
14-520549 Spacer 9H x 16W x 15D-L PEEK Lordotic (7°) In distribution
14-520580 SOLI-C SPACER 10HX18WX14D-L In distribution
14-520598 Spacer 8H x 18W x 16D-L PEEK Lordotic (7°) In distribution
14-520572 SOLI-C SPACER 12HX18WX12D-L In distribution
14-520558 Spacer 8H x 16W x 16D-L PEEK Lordotic (7°) In distribution
14-520792 SOLI-C SPACER 12HX18WX15D-P In distribution
14-520532 Spacer 12H x 16W x 12D-L PEEK Lordotic (7°) In distribution
14-520508 SOLI-C SPACER 8HX14WX12D-L In distribution
14-520560 SOLI-C SPACER 10HX16WX16D-L In distribution
14-520791 Spacer 11H x 18W x 15D-P PEEK Parallel In distribution
14-520577 Spacer 7H x 18W x 14D-L PEEK Lordotic (7°) In distribution
14-520580 Spacer 10H x 18W x 14D-L PEEK Lordotic (7°) In distribution
14-520548 SOLI-C SPACER 8HX16WX15D-L In distribution
14-520527 SOLI-C SPACER 7HX16WX12D-L In distribution
14-520519 Spacer 9H x 14W x 14D-L PEEK Lordotic (7°) In distribution
14-520550 SOLI-C SPACER 10HX16WX15D-L In distribution
14-531725E 3.75 mm x 15 mm Screw In distribution
14-531713 SOLI-C 3.5X13MM SCREW In distribution
14-520589 SOLI-C SPACER 9HX18WX15D-L In distribution
14-520738 SOLI-C SPACER 8HX16WX14D-P In distribution
14-520520 Spacer 10H x 14W x 14D-L PEEK Lordotic (7°) In distribution
14-520630 SOLI-C SPACER 10HX20WX16D-L In distribution
14-520510 Spacer 10H x 14W x 12D-L PEEK Lordotic (7°) In distribution
14-520708 Spacer 8H x 14W x 12D-P PEEK Parallel In distribution
14-520546 Spacer 6H x 16W x 15D-L PEEK Lordotic (7°) In distribution
14-520739 Spacer 9H x 16W x 14D-P PEEK Parallel In distribution
14-531715 SOLI-C 3.5X15MM SCREW In distribution
14-520619 Spacer 9H x 20W x 15D-L PEEK Lordotic (7°) In distribution
14-531724 SOLI-C 3.75X14MM SCREW In distribution
14-520742 Spacer 12H x 16W x 14D-P PEEK Parallel In distribution
14-520632 SOLI-C SPACER 12HX20WX16D-L In distribution
14-531722 SOLI-C 3.75X12MM SCREW In distribution
14-520602 SOLI-C SPACER 12HX18WX16D-L In distribution
14-520788 Spacer 8H x 18W x 15D-P PEEK Parallel In distribution
14-520710 SOLI-C SPACER 10HX14WX12D-P In distribution
14-520526 Spacer 6H x 16W x 12D-L PEEK Lordotic (7°) In distribution
14-520551 Spacer 11H x 16W x 15D-L PEEK Lordotic (7°) In distribution
14-520559 SOLI-C SPACER 9HX16WX16D-L In distribution
14-520549 SOLI-C SPACER 9HX16WX15D-L In distribution
14-520588 Spacer 8H x 18W x 15D-L PEEK Lordotic (7°) In distribution
14-520707 Spacer 7H x 14W x 12D-P PEEK Parallel In distribution
14-520567 SOLI-C SPACER 7HX18WX12D-L In distribution
14-520599 SOLI-C SPACER 9HX18WX16D-L In distribution
14-520506 SOLI-C SPACER 6HX14WX12D-L In distribution
14-520601 SOLI-C SPACER 11HX18WX16D-L In distribution
14-531714 SOLI-C 3.5X14MM SCREW In distribution
14-520546 SOLI-C SPACER 6HX16WX15D-L In distribution
14-531712 SOLI-C 3.5X12MM SCREW In distribution
14-520599 Spacer 9H x 18W x 16D-L PEEK Lordotic (7°) In distribution
14-520511 Spacer 11H x 14W x 12D-L PEEK Lordotic (7°) In distribution
14-520617 Spacer 7H x 20W x 15D-L PEEK Lordotic (7°) In distribution
14-520621 SOLI-C SPACER 11HX20WX15D-L In distribution
14-520530 SOLI-C SPACER 10HX16WX12D-L In distribution
14-520551 SOLI-C SPACER 11HX16WX15D-L In distribution
14-520739 SOLI-C SPACER 9HX16WX14D-P In distribution
14-520626 SOLI-C SPACER 6HX20WX16D-L In distribution
14-520738 Spacer 8H x 16W x 14D-P PEEK Parallel In distribution
14-520528 SOLI-C SPACER 8HX16WX12D-L In distribution
14-520521 Spacer 11H x 14W x 14D-L PEEK Lordotic (7°) In distribution
14-520567 Spacer 7H x 18W x 12D-L PEEK Lordotic (7°) In distribution
14-520532 SOLI-C SPACER 12HX16WX12D-L In distribution
14-520507 SOLI-C SPACER 7HX14WX12D-L In distribution
14-520509 SOLI-C SPACER 9HX14WX12D-L In distribution
14-520578 SOLI-C SPACER 8HX18WX14D-L In distribution
14-520709 Spacer 9H x 14W x 12D-P PEEK Parallel In distribution
14-520742 SOLI-C SPACER 12HX16WX14D-P In distribution
14-520740 Spacer 10H x 16W x 14D-P PEEK Parallel In distribution
14-520611 Spacer 11H x 20W x 14D-L PEEK Lordotic (7°) In distribution
14-520576 Spacer 6H x 18W x 14D-L PEEK Lordotic (7°) In distribution
14-520711 SOLI-C SPACER 11HX14WX12D-P In distribution
14-520568 SOLI-C SPACER 8HX18WX12D-L In distribution
14-520626 Spacer 6H x 20W x 16D-L PEEK Lordotic (7°) In distribution
14-520616 SOLI-C SPACER 6HX20WX15D-L In distribution
14-520628 Spacer 8H x 20W x 16D-L PEEK Lordotic (7°) In distribution

Showing 250 of 256 catalogue numbers.

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Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K152622 2016-07-08
K151064 2015-08-12

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.

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340,248device records, each naming its maker
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