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)

SPINAL SURGERY FRAME

K-Number: K771020 · 1977-06-17

ApplicantOrthopedic Systems, Inc.
Decision Date1977-06-17
Product CodeJEB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPINAL SURGERY FRAME 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 1977-06-17 under 510(k) number K771020. The device is classified under product code JEB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL SURGERY FRAME?

SPINAL SURGERY FRAME is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K771020.

When did SPINAL SURGERY FRAME receive FDA 510(k) clearance?

SPINAL SURGERY FRAME received FDA 510(k) clearance on 1977-06-17, under 510(k) number K771020.

Who is the listed applicant for SPINAL SURGERY FRAME?

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 SPINAL SURGERY FRAME?

The FDA product code for SPINAL SURGERY FRAME is JEB.

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 TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

View all 95 devices →

Related Devices (Code: JEB)

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.

K905816ORTHOVISION TABLEAmerican Sterilizer Co.K900405SCHOLTEN FRAMEScholten Surgical Instruments, Inc.K891917ORTHO-J, INC. BEK-JS-004Ortho-J, Inc.K891387WILLIAMS BELT & BOOTArthro-Medic, Inc.K881101K ORTHOPEDIC TABLEInstrumentation Specialties, Inc.K880263OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSIONOrthopedic Systems, 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.

↑