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)

SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM

K-Number: K112025 · 2011-09-15

ApplicantSpinal USA
Decision Date2011-09-15
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal USA. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K112025. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM?

SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Spinal USA. The 510(k) number is K112025.

When did SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM receive FDA 510(k) clearance?

SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM received FDA 510(k) clearance on 2011-09-15, under 510(k) number K112025.

Who is the listed applicant for SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM?

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

What is the FDA product code for SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM?

The FDA product code for SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM is KWP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spinal USA 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.

K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICEK130863FACET SCREW SYSTEMK131343REFORM PEDICLE SCREW SYSTEMK130279REFORM PEDICLE SCREW SYSTEMK130445VAULT ALIF SYSTEMK122931S-LOK PSS SYSTEM

View all 23 devices →

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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.

↑