CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM— 510(k) K940631
Substantially Equivalent for Some IndicationsCross Medical Products, Inc.
FDA 510(k) clearance K940631 for CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM, Substantially Equivalent for Some Indications on 1995-07-13. Applicant: Cross Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Cross Medical Products, Inc.
- Product code
- Code MNH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- 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 MNH
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
- K924381 — PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
- K920116 — PWB LUMBOSACRAL SPINE SYSTEM
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.