Tryptik Ca Anterior Intersomatic Cervical Cage, Models Mos-Ca 12 05-S, Mos-Ca 12 O6-S

FDA 510(k) K091873 · Spineart

Substantially Equivalent

510(k) numberK091873

Submission

Device name
Tryptik Ca Anterior Intersomatic Cervical Cage, Models Mos-Ca 12 05-S, Mos-Ca 12 O6-S
Applicant
Spineart
Geneva, CH
Received
June 23, 2009
Decision date
September 18, 2009
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ODP – Intervertebral Fusion Device With Bone Graft, Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3080
Specialty
Orthopedic
Implant
Yes

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code ODP

510(k)DeviceApplicantDecision
K262595VariLift-C Cervical Interbody Fusion SystemODP · Special Wenzel Spine, Inc.08/26/2026SE
K262489BluEX Cervical Expandable Cage SystemODP · Special L&K BIOMED Co., Ltd.08/18/2026SE
K2530413d Cage CervicalODP · Traditional Fims Co., Ltd.07/23/2026SE
K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special Stryker Spine07/17/2026SE
K254130C.A. Medical Interbody Fusion SystemODP · Special C.A. Medical, LLC07/08/2026SE
K260840BluEX Cervical Expandable Cage SystemODP · Traditional L&K BIOMED Co., Ltd.05/16/2026SE
K260850Osteomni Spinal Cages SystemODP · Traditional Osteomni, Inc.05/12/2026SE
K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special Zsfab, Inc.04/24/2026SE
K253260ORIO-3D Cage SystemODP · Traditional SpineCraft04/16/2026SE
K260340HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional HC Biologics, LLC04/13/2026SE

More from HC Biologics, LLC

510(k)DeviceDecision
K261049Scala® TLMAX · Traditional 08/20/2026SE
K262639BAGUERA® C Cervical Disc Surgical InstrumentsQLQ · Traditional 08/14/2026SE
K261205SPINEART Navigation Instrument SystemOLO · Traditional 07/29/2026SE
K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional 05/01/2026SE
K254158SPINEART Navigation Instrument SystemOLO · Special 04/09/2026SE
K242933SPINEART Navigation Instrument SystemOLO · Traditional 06/18/2025SE
K242890SPINEART Navigation Instrument SystemOLO · Traditional 03/07/2025SE
K242589Scarlet® AL-TMAX · Traditional 10/23/2024SE
K241644SPINEART Navigation Instrument SystemOLO · Special 08/07/2024SE
K241321Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional 07/18/2024SE

Questions and answers

When was Tryptik Ca Anterior Intersomatic Cervical Cage, Models Mos-Ca 12 05-S, Mos-Ca 12 O6-S cleared by the FDA?

Tryptik Ca Anterior Intersomatic Cervical Cage, Models Mos-Ca 12 05-S, Mos-Ca 12 O6-S (K091873) received a 510(k) decision of Substantially Equivalent on September 18, 2009, 87 days after the submission was received.

What is the product code of K091873?

The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.