510(k) K121874
- Device
- G7 ACETABULAR SYSTEM
- Applicant
- BIOMET MANUFACTURING CORP.
- 510(k) number
- K121874
- Product code
- PBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-11-23
- Date received
- 2012-06-27
- Regulation
- 888.3310
- Classification name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BECKY EARL
- Address
- 56 E. Bell Dr., P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3002807315
- 3012319330
- 3015207155
- 3010173425
- 8043792
- 3004748528
- 3020282716
- 1828464
- 3005061536
- 1834379
- 1450662
- 1423662
- 3002807310
- 3006801265
- 9617840
- 3012725451
- 1424263
- 1825034
- 3010386387
- 3005360851
- 3013176080
- 2648920
- 3007923096
- 3035366890
- 3013055499
- 1822565
- 3014302784
- 3004153896
- 1526534
- 1529009
Source Documents#
Other 510(k) Records For Product Code PBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212512 | G7® Vivacit-E® Freedom® Constrained Liner | Zimmer, Inc. | 2022-04-28 |
Legacy Summary#
summary
FDA Review#
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