510(k) K052483
- Device
- SYNTHES (USA) SPHERICAL WASHERS
- Applicant
- SYNTHES (USA)
- 510(k) number
- K052483
- Product code
- NDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-04
- Date received
- 2005-09-09
- Regulation
- 888.3030
- Classification name
- Washer, Bolt, Nut, Non-spinal, Metallic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LISA M BOYLE
- Address
- 1302 Wrights Ln. E. West Chester PA US 19380 19380
FDA Registration Numbers#
- 3007366790
- 3038503932
- 9613369
- 3021008900
- 2031009
- 3022142628
- 3002907620
- 3014527928
- 1020279
- 3034676720
- 3007738812
- 2029275
- 3007420745
- 3009417901
- 3008812560
- 3036756245
- 3036042032
- 3025603301
- 1643264
- 3033509898
- 1822565
- 3004049923
- 3015399803
- 3008744062
Source Documents#
Legacy Summary#
summary
FDA Review#
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