MAYFIELD ADULT DISPOSABLE SKULL PIN— 510(k) K932860
Substantially EquivalentOhio Medical Instrument Co., Inc.
FDA 510(k) clearance K932860 for MAYFIELD ADULT DISPOSABLE SKULL PIN, Substantially Equivalent on 1993-09-28. Applicant: Ohio Medical Instrument Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Ohio Medical Instrument Co., Inc.
- 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
- Cincinnati, OH, US
Recent devices under product code HBL
view all- 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)
More clearances from Ohio Medical Instrument Co., Inc.
view all- K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K013428 — MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
- K992843 — THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
- K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
- K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.