Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AccuLIF TL and PL Cage

K-Number: K160715 · 2016-07-08

ApplicantStryker Corporation
Decision Date2016-07-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AccuLIF TL and PL Cage is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K160715. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccuLIF TL and PL Cage?

AccuLIF TL and PL Cage is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Stryker Corporation. The 510(k) number is K160715.

When did AccuLIF TL and PL Cage receive FDA 510(k) clearance?

AccuLIF TL and PL Cage received FDA 510(k) clearance on 2016-07-08, under 510(k) number K160715.

Who is the listed applicant for AccuLIF TL and PL Cage?

The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuLIF TL and PL Cage?

The FDA product code for AccuLIF TL and PL Cage is MAX.

Other records listing Stryker Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemK253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemK253202Hoffmann LRF SystemK251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemK250163T2 Alpha Femur Retrograde Nailing SystemK242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

View all 164 devices →

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑