PWB LUMBOSACRAL SPINE SYSTEM— 510(k) K920116
Substantially Equivalent for Some IndicationsCross Medical Products, Inc.
FDA 510(k) clearance K920116 for PWB LUMBOSACRAL SPINE SYSTEM, Substantially Equivalent for Some Indications on 1992-04-10. Applicant: Cross Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Cross Medical Products, Inc.
- Product code
- Code KWP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Concord, CA, US
Recent devices under product code KWP
view allMore clearances from Cross Medical Products, Inc.
view all- K974749 — SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS
- K973836 — SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
- K950709 — SYNERGY TI ANTERIOR SPINAL SYSTEM
- K940631 — CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
- K924381 — PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.