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)

SCULPTOR ROBOTIC GUIDANCE ARM (RGA)

K-Number: K121765 · 2013-01-11

ApplicantStanmore Implants Worldwide , Ltd.
Decision Date2013-01-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SCULPTOR ROBOTIC GUIDANCE ARM (RGA) is the device name listed in this FDA 510(k) record. The listed applicant is Stanmore Implants Worldwide , Ltd.. It received FDA 510(k) clearance on 2013-01-11 under 510(k) number K121765. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCULPTOR ROBOTIC GUIDANCE ARM (RGA)?

SCULPTOR ROBOTIC GUIDANCE ARM (RGA) is a medical device that received FDA 510(k) clearance on 2013-01-11. The listed applicant is Stanmore Implants Worldwide , Ltd.. The 510(k) number is K121765.

When did SCULPTOR ROBOTIC GUIDANCE ARM (RGA) receive FDA 510(k) clearance?

SCULPTOR ROBOTIC GUIDANCE ARM (RGA) received FDA 510(k) clearance on 2013-01-11, under 510(k) number K121765.

Who is the listed applicant for SCULPTOR ROBOTIC GUIDANCE ARM (RGA)?

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

What is the FDA product code for SCULPTOR ROBOTIC GUIDANCE ARM (RGA)?

The FDA product code for SCULPTOR ROBOTIC GUIDANCE ARM (RGA) is OLO.

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 Stanmore Implants Worldwide , 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.

K121056METS MODULAR PROXIMAL FEMURK121029METS MODULAR DISTAL FEMURK121055METS MODULAR TOTAL FEMURK120992METS SMILES TOTAL KNEE REPLACEMENTK092138JTS EXTENDEABLE IMPLANT

Related Devices (Code: OLO)

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.

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLCK261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

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.

↑