FDA 510(k)

HIP, FEMUR AND HUMERUS RETRACTOR

K-Number: K880151 · 1988-02-18

ApplicantTwenty-First Century Orthopedics, Inc.

Decision Date1988-02-18

Product CodeGAD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HIP, FEMUR AND HUMERUS RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Twenty-First Century Orthopedics, Inc.. It received FDA 510(k) clearance on 1988-02-18 under 510(k) number K880151. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIP, FEMUR AND HUMERUS RETRACTOR?

HIP, FEMUR AND HUMERUS RETRACTOR is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is Twenty-First Century Orthopedics, Inc.. The 510(k) number is K880151.

When did HIP, FEMUR AND HUMERUS RETRACTOR receive FDA 510(k) clearance?

HIP, FEMUR AND HUMERUS RETRACTOR received FDA 510(k) clearance on 1988-02-18, under 510(k) number K880151.

Who is the listed applicant for HIP, FEMUR AND HUMERUS RETRACTOR?

The FDA 510(k) record lists Twenty-First Century Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIP, FEMUR AND HUMERUS RETRACTOR?

The FDA product code for HIP, FEMUR AND HUMERUS RETRACTOR is GAD.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: GAD)

K152538JRP Wound SpreaderJ.R. Parker, LLC K151104OTELO LLSpineart K132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgical K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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.