CUSTOMED ORTHOPEDIC II— 510(k) K902888
Substantially EquivalentCustomed, Inc.
FDA 510(k) clearance K902888 for CUSTOMED ORTHOPEDIC II, Substantially Equivalent on 1990-09-10. Applicant: Customed, Inc.. Device class: 2.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code LRO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carolina Puerto Rico, US
Recent devices under product code LRO
view allMore clearances from Customed, Inc.
view all- K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
- K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
- K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277
- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K962596 — CUSTOMED BLOOD EXTRACTION KIT
Adverse events under product code LRO
product code LRO- Injury
- 975
- Malfunction
- 14,038
- Other
- 2
- Total
- 15,015
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.