510(k) K183194
- Device
- Arthrex Eclipse Shoulder Prosthesis System
- Applicant
- Arthrex Inc.
- 510(k) number
- K183194
- Product code
- QHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-26
- Date received
- 2018-11-19
- Regulation
- 888.3660
- Classification name
- Total Shoulder Arthroplasty System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David L Rogers
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 1220246
- 3003403260
- 3010331645
- 3014262693
- 3016851379
- 3020704423
- 3019269298
- 3015806723
- 3002579136
- 1054811
- 3012818475
- 3010400367
- 3000258338
- 3012275107
- 3014004349
- 3010178296
- 3009882462
- 3015231789
Source Documents#
Legacy Summary#
summary
FDA Review#
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