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)

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01

K-Number: K000797 · 2000-04-03

ApplicantOrthopaedic Biosystems, Ltd.
Decision Date2000-04-03
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems, Ltd.. It received FDA 510(k) clearance on 2000-04-03 under 510(k) number K000797. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01?

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 is a medical device that received FDA 510(k) clearance on 2000-04-03. The listed applicant is Orthopaedic Biosystems, Ltd.. The 510(k) number is K000797.

When did OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 receive FDA 510(k) clearance?

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 received FDA 510(k) clearance on 2000-04-03, under 510(k) number K000797.

Who is the listed applicant for OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01?

The FDA 510(k) record lists Orthopaedic Biosystems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01?

The FDA product code for OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 is JDR.

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 Orthopaedic Biosystems, Ltd. 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.

K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATIONK983169POLYMER THREADED ANCHORK982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONK972326PEBA ANCHOR/SUTURE COMBINATIONK963420CANCELLOUS SCREW WASHERK963432GUIDE WIRES FOR CANNULATED SCREWS

View all 11 devices →

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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.

↑