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510(k) K241883

DORO 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) by Pro Med Instruments GmbH — Product Code HBL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 26, 2024
Date Received: June 28, 2024
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Holder, Head, Neurosurgical (Skull Clamp)
Device Class: Class II
Regulation Number: 882.4460
Review Panel: NE
Submission Type

Other clearances by Pro Med Instruments GmbH

K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101. (April 24, 2024)
K203505 — DORO QR3 Headrest System (Aluminum) (March 29, 2021)
K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable S (June 2, 2020)
K191740 — DORO LUCENT® iXI and iMRI Headrest System (February 21, 2020)
K191979 — DORO QR3 XTom Headholder System (October 22, 2019)

Other clearances for product code HBL

K250423 — mb-FIX Cranial Stabilization Systems (November 6, 2025)
K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101. (April 24, 2024)
K203505 — DORO QR3 Headrest System (Aluminum) (March 29, 2021)
K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable S (June 2, 2020)
K191740 — DORO LUCENT® iXI and iMRI Headrest System (February 21, 2020)
K191701 — Arcus Head Fixation Frame (November 15, 2019)
K191979 — DORO QR3 XTom Headholder System (October 22, 2019)
K163322 — TZ SKULL PIN Adult (February 23, 2017)
K142238 — MAYFIELD Skull Clamp (November 24, 2014)
K141950 — HFD100 ROCKER ARM ACCESSORY (September 4, 2014)