Product code HBL— Neurology
CODMAN SKULL CLAMP
- Classification name
- Holder, Head, Neurosurgical (Skull Clamp)
- Device class
- Class 2
- Regulation
- 21 CFR 882.4460
- Advisory panel
- Neurology
- Total cleared
- 50
- First cleared
- Most recent
Market context for product code HBL
FDA has cleared devices under product code HBL between 1982 and 2025, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2021
- 2020
- 2019
- 2017
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2005
Top applicants under product code HBL
Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HBL
- K250423 — mb-FIX Cranial Stabilization Systems
- K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00) +4 more
- K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
- K203505 — DORO QR3 Headrest System (Aluminum)
- K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
- K191740 — DORO LUCENT® iXI and iMRI Headrest System
- K191701 — Arcus Head Fixation Frame
- K191979 — DORO QR3 XTom Headholder System
- K163322 — TZ SKULL PIN Adult
- K142238 — MAYFIELD Skull Clamp
- K141950 — HFD100 ROCKER ARM ACCESSORY
- K122225 — STERILE RADIOLUCENT SKULL PINS
- K130389 — MAYFIELD INFINITY XR2 SKULL CLAMP
- K120633 — MAYFIELD SKULL CLAMP
- K113748 — IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
- K103493 — HEAD FIATION DEVICE (HFD 100)
- K083803 — FIXIT HEADREST CLAMP SYSTEM
- K091439 — HEAD FIXATION ARC AND TABLE BASE
- K090695 — DINKLER SURGICAL SKULL CLAMP, MODEL 0308
- K090506 — MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
- K081401 — MAYFIELD MR/X-RAY SKULL CLAMP
- K073163 — LIMITED ARTIFACT SKULL PIN, MODEL 0107
- K072208 — MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
- K071458 — MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
- K063494 — DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
- K053045 — MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K051440 — MAYFIELD INFINITY SKULL CLAMP
- K050319 — MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
- K032331 — DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
- K031885 — NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
- K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K002990 — VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
- K002276 — PSI SKULL CLAMP
- K001808 — DORO HEADREST SYSTEM
- K955012 — MIZUHO RADIOLUCENT HEAD FRAME
- K953124 — MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
- K941558 — MAYFIELD CHILD DISPOSABLE SKULL PIN
- K934289 — MAYFIELD RADIOLUCENT SKULL CLAMP
- K932807 — MAYFIELD* A-2000 SKULL CLAMP
- K932860 — MAYFIELD ADULT DISPOSABLE SKULL PIN
- K923789 — MAYFIELD ADULT DISPOSABLE SKULL PIN
- K912005 — CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
- K911723 — CODMAN DISPOSABLE SKULL PINS
- K913170 — CODMAN SKULL CLAMP
- K911772 — GARDNER PINS (ADULT & CHILD)
- K912011 — CODMAN SKULL CLAMP
- K901393 — MAINZ HEAD FIXATION BY PERNECZKY
- K893911 — MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
- K874298 — MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
- K821772 — SURGITA/MIZHO MICRONEUROSURGERY HEAD FR
Data sourced from openFDA. This site is unofficial and independent of the FDA.