Royal Oak Medical Devices 510 K

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510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K110177

510 (k) Number. K110177. Device Name. HELENA SYSTEM. Applicant. ROYAL OAK MEDICAL DEVICES. 39533 WOODWARD AVENUE. BLOOMFIELD …

Kiiu 017? - Food and Drug Administration

https://www.accessdata.fda.gov/cdrh_docs/pdf11/K110177.pdf

510(k) Summary Royal Oak Medical Devices APR 2 1 20i1 Helena System Premarket Notification SUBMITTED BY Royal Oak Medical Devices 39533 Woodward Avenue …

DEC 2011, - accessdata.fda.gov

https://www.accessdata.fda.gov/cdrh_docs/pdf11/K110046.pdf

Royal Oak Medical Devices Athena Pedlicle Screw System 510(K) Summary SUBMITTED BY Royal Oak Medical Devices 39533 Woodward Avenue, Suite 175 …

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=k110046

www.accessdata.fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn_template.cfm?id=k110177

Device Classification Name: intervertebral fusion device with bone graft, lumbar: 510(k) Number: K110177: Device Name: HELENA SYSTEM: Applicant

Helena System 510(k) FDA Premarket Notification K110177 …

https://fda.report/PMN/K110177

Device ID: K110177: 510k Number: K110177: Device Name: HELENA SYSTEM: Classification: Intervertebral Fusion Device With Bone Graft, Lumbar: Applicant: ROYAL …

510(k) Clearances | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

510 (k) Clearances Overview Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their …

Orthopedic Spinal Implants & Instruments | ROMD

https://www.royaloakmed.com/

Materials: Titanium, Cobalt Chrome, Stainless, PEEK, Thermoplastics. 3 Axis to 9 Axis CNC Turning, capacity 5mm to 450 mm diameter x 1000mm long. 3, 4 and 5 …

January 2023 510(K) Clearances | FDA

https://cacmap.fda.gov/medical-devices/510k-clearances/january-2023-510k-clearances

Inc. 510 (k) NO: K213423 (Traditional) ATTN: Tim Hanson PHONE NO : 857 3669333 280 Summer St. 4th Floor SE DECISION MADE: 06-JAN-23 Boston MA 02210 …