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FDA 510(k)

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

K-Number: K193438 · 2020-06-02

ApplicantPro Med Instruments GmbH
Decision Date2020-06-02
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) is a medical device manufactured by Pro Med Instruments GmbH. It received FDA 510(k) clearance on 2020-06-02 under approval number K193438. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) is a medical device that received FDA 510(k) clearance on 2020-06-02. It is manufactured by Pro Med Instruments GmbH. The 510(k) number is K193438.

When was DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) approved by the FDA?

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) received FDA 510(k) clearance on 2020-06-02, under approval number K193438.

What company makes DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) is manufactured by Pro Med Instruments GmbH.

What is the FDA product code for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

The FDA product code for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) is HBL.

Related Clinical Trials

NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07526805 Digital Manufacturing and Periodontal Performance of CAD/CAM-Customized Orthodontic Molar Bands Compared With Standard Stainless-Steel Bands COMPLETED NCT07523776 Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41265798 Comparison of two models of biofilm formation on reusable stainless steel medical device material. The Journal of hospital infection (2026)

Other Devices by Pro Med Instruments GmbH

K191979DORO QR3 XTom Headholder System K191740DORO LUCENT® iXI and iMRI Headrest System K203505DORO QR3 Headrest System (Aluminum) K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

Related Devices (Code: HBL)

K163322TZ SKULL PIN AdultTz Medical, Inc. K191701Arcus Head Fixation FrameMri Interventions, Inc. K191979DORO QR3 XTom Headholder SystemPro Med Instruments GmbH K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbH

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.

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