Product code HBW— Neurology
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
- Classification name
- Fastener, Plate, Cranioplasty
- Device class
- Class 2
- Regulation
- 21 CFR 882.5360
- Advisory panel
- Neurology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code HBW
FDA has cleared devices under product code HBW between 2001 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
- 2017
- 2015
- 2010
- 2001
Top applicants under product code HBW
Recent clearances under product code HBW
- 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)
- K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
- K001353 — MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.