Holder, Head, Neurosurgical (Skull Clamp)
Regulation 882.4460
1510(k)s in 12 months (50 all time)
1recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in HBL
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 10 | 4 |
| Pro Med Instruments GmbH | 9 | 5 |
| Ohio Medical Instrument Co., Inc. | 7 | 0 |
| Codman & Shurtleff, Inc. | 5 | 0 |
| Deerfield Imaging | 0 | 3 |
| Imris, Inc. | 3 | 0 |
| Dinkler Surgical Devices, Inc. | 2 | 0 |
| Brainlab AG | 1 | 0 |
| Downs Surgical , Ltd. | 1 | 0 |
| Engineered Orthopedic Technologies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | IMRIS Imaging Inc Brand Name: HFD100
Product Name: Head Fixation Device HFD100
Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600
Software Version: Not Applicable
P Open, Classified |
HBL | K103493 |
| May 28, 2025 | Pro-Med Instruments Gmbh DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) Open, Classified |
HBL | K001808 |
| Feb 17, 2022 | Deerfield Imaging, Inc. Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating Terminated |
HBL | K103493 |
| Nov 11, 2020 | Integra LifeSciences Corp. Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000 Terminated |
HBL | K932807 |
| Jun 26, 2019 | Deerfield Imaging, Inc. IMRIS MR/X-ray head fixation device, Model HFD200 Terminated |
HBL | K113748 |
| Sep 17, 2018 | Pro-Med Instruments Gmbh DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries Terminated |
HBL | K032331 |
| Sep 17, 2018 | Pro-Med Instruments Gmbh DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries Terminated |
HBL | K032331 |
| Sep 17, 2018 | Pro-Med Instruments Gmbh DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries Terminated |
HBL | K032331 |
| Nov 2, 2017 | Pro-Med Instruments Gmbh pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY
The DORO(R) Skull Pins are inserted into the receptacles of th Terminated |
HBL | K001808 |
| Aug 14, 2017 | Deerfield Imaging IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw Terminated |
HBL | K103493 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - Mayfield Disposable Skull Pin;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number A1072;
EXP (repackager), Integra (OEM)
Holder, head, neurosurgical (skull c Terminated |
HBL | None listed |
| Nov 13, 2013 | Integra LifeSciences Corp. Composite Series Skull Clamp, one clamp per tote.
The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the pa Terminated |
HBL | K120633 |
| Dec 19, 2012 | Integra LifeSciences Corporation MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633.
The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rig Terminated |
HBL | K120633 |
| Jul 27, 2004 | Integra LifeSciences Corporation MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 Terminated |
HBL | K021604 |
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