MAINZ HEAD FIXATION BY PERNECZKY— 510(k) K901393
Substantially EquivalentZeppelin GmbH
FDA 510(k) clearance K901393 for MAINZ HEAD FIXATION BY PERNECZKY, Substantially Equivalent on 1990-09-04. Applicant: Zeppelin GmbH. Device class: 2.
Clearance details
- Applicant
- Zeppelin GmbH
- 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
- West Germany, DE
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 Zeppelin GmbH
view allAdverse 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.