CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM— 510(k) K071138
Substantially EquivalentProsurg, Inc.
FDA 510(k) clearance K071138 for CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM, Substantially Equivalent on 2007-08-15. Applicant: Prosurg, Inc.. Device class: 2.
Clearance details
- Applicant
- Prosurg, Inc.
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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More clearances from Prosurg, Inc.
view all- K152511 — Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
- K152466 — Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
- K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
- K120766 — ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
- K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.