510(k) K070565
- Device
- COFIELD TOTAL SHOULDER SYSTEM
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K070565
- Product code
- MBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-05-18
- Date received
- 2007-02-28
- Regulation
- 888.3670
- Classification name
- Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARLON D RIDLEY
- Address
- 1450 E. Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 9616671
- 3004748528
- 1836116
- 1834379
- 1422572
- 1020279
- 3008868758
- 1000200989
- 3011015572
- 3014315560
- 3011274144
- 3004641308
- 1064858
- 3017397663
- 1221934
- 3010163695
- 1000517406
- 1822565
- 3007993775
- 3027484613
- 3014302784
- 3010057495
- 1529009
- 8043792
- 3016851379
- 3015916578
- 3014680795
- 3012725451
- 1450662
- 3006128100
- 3006801265
- 3021008900
- 3013176080
- 3004153896
- 1424263
- 3010386387
- 3015516266
- 3026771806
- 3010178296
- 1644408
- 3008534770
- 3009546990
- 3010331645
- 3011461101
- 3006946276
- 3002806603
- 1835831
- 3008744062
- 3007923096
- 3002579136
- 1818910
- 9617840
- 8010379
- 1825034
- 3008791302
- 9681465
- 1835444
- 3003898228
- 3004976965
- 2029275
- 3012319330
- 3035366890
- 3008021110
- 8010916
- 3009417901
- 3005180920
- 3008812251
- 3015806723
- 3005497913
- 3010009693
- 3015399803
- 1721676
- 3007366790
- 1220246
- 3038503932
- 3002806470
- 3008421730
- 3008110533
- 1423662
Source Documents#
Other 510(k) Records For Product Code MBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | 2026-04-13 |
| K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | 2025-08-11 |
| K250848 | Identity Shoulder System | Zimmer, Inc. | 2025-07-02 |
| K240876 | Identity Shoulder System | Zimmer, Inc. | 2024-06-12 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024-01-11 |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023-12-21 |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023-11-13 |
| K231516 | INHANCE™ Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | 2023-07-21 |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023-02-03 |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022-10-06 |
| K213856 | Identity Shoulder System | Zimmer, Inc. | 2022-09-15 |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | 2022-06-08 |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022-05-19 |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-05-20 |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020-12-17 |
Legacy Summary#
summary
FDA Review#
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