510(k) K070293
- Device
- BENVENUE VCF OSTEO COIL SYSTEM
- Applicant
- BENVENUE MEDICAL, INC.
- 510(k) number
- K070293
- Product code
- OCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-07-10
- Date received
- 2007-01-31
- Regulation
- 888.4540
- Classification name
- Spinal Channeling Instrument, Vertebroplasty
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURENT SCHALLER
- Address
- 1235 Pear Ave., #111 Mountain View CA US 94043 94043
FDA Registration Numbers#
- 3010531060
- 3008583793
- 2648623
- 3030183061
- 3006798004
- 3010663372
- 2649614
- 1450662
- 1211566
- 3015967359
- 3005067367
- 1649518
- 1061927
- 3008110533
- 8040278
- 1644312
- 3003595343
- 3004598644
- 3012764194
- 3016789487
- 3013846070
- 3010509633
- 2029275
- 9613926
- 3009417901
- 3005180920
- 3004111573
- 1220477
- 3008812560
- 9617616
- 3009599228
- 3035858921
- 3014200871
- 3038195984
- 3011489618
- 2648666
- 1417485
- 9614841
- 3002806603
- 3027518990
- 3015399803
- 9615788
- 3010303097
- 3005596514
- 2953359
- 3016112537
- 1123169
- 3010898856
Source Documents#
Legacy Summary#
summary
FDA Review#
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