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AnyPlus Cervical PEEK Cage System

GS Medical Co., Ltd. · Model 1182-5412 · UDI-DI 08806378344843

ODP Prescription
1
510(k) clearances
1,116
Adverse events (3 deaths)
11
Recalls
345
Facilities

Description

The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical PEEK Cage devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® Cervical PEEK Cage device is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage is designed for interbody stabilization of the cervical spine.

Recalls

DateFirmReason
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2020-09-30XTANT MedicalCervical Implants contain a label that incorrectly identifies the grade of titanium used.
2013-10-07RTI Surgical, Inc.As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requ
2013-02-05SpineNetThe recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to
2012-06-15Exactech, Inc.Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Inter
2011-09-23Synthes USA (HQ), Inc.LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.