GUARDIAN INFLATABLE BONE EXPANDER SYSTEM— 510(k) K111593
Substantially EquivalentBm Korea Co., Ltd.
FDA 510(k) clearance K111593 for GUARDIAN INFLATABLE BONE EXPANDER SYSTEM, Substantially Equivalent on 2011-11-18. Applicant: Bm Korea Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Bm Korea Co., Ltd.
- Product code
- Code NDN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
Recent devices under product code NDN
view allMore clearances from Bm Korea Co., Ltd.
view all- K143006 — GUARDIAN-SG Inflatable Bone Expander System
- K122518 — SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
- K120353 — SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
- K111820 — SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
Adverse events under product code NDN
product code NDN- Death
- 24
- Injury
- 407
- Malfunction
- 1,975
- Total
- 2,406
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.