HBL — Holder, Head, Neurosurgical (Skull Clamp) Class II
FDA product code HBL covers "Holder, Head, Neurosurgical (Skull Clamp)", a Class II medical device regulated under 21 CFR 882.4460. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HBL
- Device Class
- Class II
- Regulation Number
- 882.4460
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250423 | medical bees | mb-FIX Cranial Stabilization Systems | November 6, 2025 |
| K241883 | pro med instruments | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); D | July 26, 2024 |
| K240319 | pro med instruments | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101. | April 24, 2024 |
| K203505 | pro med instruments | DORO QR3 Headrest System (Aluminum) | March 29, 2021 |
| K193438 | pro med instruments | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable S | June 2, 2020 |
| K191740 | pro med instruments | DORO LUCENT® iXI and iMRI Headrest System | February 21, 2020 |
| K191701 | mri interventions | Arcus Head Fixation Frame | November 15, 2019 |
| K191979 | pro med instruments | DORO QR3 XTom Headholder System | October 22, 2019 |
| K163322 | tz medical | TZ SKULL PIN Adult | February 23, 2017 |
| K142238 | integra lifesciences corporation | MAYFIELD Skull Clamp | November 24, 2014 |
| K141950 | imris | HFD100 ROCKER ARM ACCESSORY | September 4, 2014 |
| K122225 | brainlab | STERILE RADIOLUCENT SKULL PINS | April 26, 2013 |
| K130389 | integra lifesciences corporation | MAYFIELD INFINITY XR2 SKULL CLAMP | April 23, 2013 |
| K120633 | integra lifesciences corporation | MAYFIELD SKULL CLAMP | May 24, 2012 |
| K113748 | imris | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | March 23, 2012 |
| K103493 | imris | HEAD FIATION DEVICE (HFD 100) | March 11, 2011 |
| K083803 | medicon eg | FIXIT HEADREST CLAMP SYSTEM | March 10, 2010 |
| K091439 | surgivision | HEAD FIXATION ARC AND TABLE BASE | August 25, 2009 |
| K090695 | dinkler surgical devices | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 | April 23, 2009 |
| K090506 | integra lifesciences corporation | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 | April 20, 2009 |