510(k) K051820
- Device
- PARALLAX EZFLOW CEMENT DELIVERY SYSTEM
- Applicant
- ARTHROCARE CORP.
- 510(k) number
- K051820
- Product code
- OAR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-09-06
- Date received
- 2005-07-05
- Regulation
- 888.4200
- Classification name
- Injector, Vertebroplasty (does Not Contain Cement)
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VALERIE DEFIESTA-NG
- Address
- 680 Vaqueros Ave. Sunnyvale CA US 94085 94085
FDA Registration Numbers#
- 1721676
- 3000270450
- 3011642792
- 3008583793
- 3024988980
- 8043746
- 2648623
- 2245304
- 3007485169
- 3006798004
- 2649614
- 3011137372
- 3015967359
- 9616662
- 1649518
- 3002807314
- 3008110533
- 3008215723
- 1928237
- 3004774118
- 1644312
- 3015309643
- 3011224555
- 3004598644
- 3016472588
- 3009465247
- 3008114965
- 3013846070
- 3010509633
- 3014615697
- 3016789487
- 3021006165
- 3016050940
- 1424263
- 3006283319
- 3009134882
- 3009417901
- 3012536737
- 3005180920
- 3004111573
- 3010173425
- 1820334
- 3008812560
- 1724474
- 3033589330
- 3008770707
- 9617616
- 3009599228
- 3035858921
- 3007017524
- 3014200871
- 3038195984
- 3015225571
- 2648666
- 1417485
- 3015487912
- 3009756327
- 3009337401
- 3010155661
- 9614841
- 3002806603
- 3027518990
- 3015399803
- 9615788
- 1721504
- 2953359
- 3012447612
- 1123169
- 3010898856
- 3006950086
Source Documents#
Legacy Summary#
summary
FDA Review#
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