MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM— 510(k) K001353
Substantially EquivalentBiomedical Ent., Inc.
FDA 510(k) clearance K001353 for MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM, Substantially Equivalent on 2001-03-13. Applicant: Biomedical Ent., Inc.. Device class: 2.
Clearance details
- Applicant
- Biomedical Ent., Inc.
- Product code
- Code HBW
- Device class
- Class 2
- Regulation
- 21 CFR 882.5360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code HBW
view all- K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- K231208 — Stryker Resorbable Fixation System
- K171152 — Stryker Universal Neuro III System AXS Screw
- K151387 — Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
- K141385 — DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
More clearances from Biomedical Ent., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.