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)

PARK CITY SHOULDER POSITIONER

K-Number: K910031 · 1991-01-24

ApplicantOrthopedic Systems, Inc.
Decision Date1991-01-24
Product CodeFWZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARK CITY SHOULDER POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1991-01-24 under 510(k) number K910031. The device is classified under product code FWZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARK CITY SHOULDER POSITIONER?

PARK CITY SHOULDER POSITIONER is a medical device that received FDA 510(k) clearance on 1991-01-24. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K910031.

When did PARK CITY SHOULDER POSITIONER receive FDA 510(k) clearance?

PARK CITY SHOULDER POSITIONER received FDA 510(k) clearance on 1991-01-24, under 510(k) number K910031.

Who is the listed applicant for PARK CITY SHOULDER POSITIONER?

The FDA 510(k) record lists Orthopedic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARK CITY SHOULDER POSITIONER?

The FDA product code for PARK CITY SHOULDER POSITIONER is FWZ.

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 Orthopedic Systems, Inc. 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK903938C FIT CUPK892503NUFFIELD TOTAL KNEEK896678SILICONE PLUG

View all 95 devices →

Related Devices (Code: FWZ)

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.

K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.K935381KAPS POSITIONING ARMAndronic Devices, Ltd.K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.K926225SPONGE COUNTERAmerican Medical Manufacturer, 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.

↑