MAYFIELD SKULL CLAMP— 510(k) K120633
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K120633 for MAYFIELD SKULL CLAMP, Substantially Equivalent on 2012-05-24. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code HBL
- Device class
- Class 2
- Regulation
- 21 CFR 882.4460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planisboro, NJ, US
Recent devices under product code HBL
view all- K250423 — mb-FIX Cranial Stabilization Systems
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- K203505 — DORO QR3 Headrest System (Aluminum)
- K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
More clearances from Integra LifeSciences Corporation
view all- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
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 →
Recalls naming K120633
K-number listed on FDA's recall record- Z-0210-2014 — 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 patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary
- Z-0559-2013 — 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 rigid skeletal fixation is necessary.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120633.
Data sourced from openFDA. This site is unofficial and independent of the FDA.