PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS— 510(k) K924381
Substantially Equivalent for Some IndicationsCross Medical Products, Inc.
FDA 510(k) clearance K924381 for PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS, Substantially Equivalent for Some Indications on 1993-05-18. 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
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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
- K920116 — PWB LUMBOSACRAL SPINE SYSTEM
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.