510(k) K972691
- Device
- ABC TOTAL ELBOW PROTHESIS
- Applicant
- BIOMET, INC.
- 510(k) number
- K972691
- Product code
- JDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-10-15
- Date received
- 1997-07-17
- Regulation
- 888.3160
- Classification name
- Prosthesis, Elbow, Semi-constrained, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KARL SCHWARTZ
- Address
- Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 9616671
- 3004748528
- 1818910
- 8010379
- 1450662
- 3002806470
- 1825034
- 3004983210
- 3008337808
- 3000931034
- 9681465
- 2183946
- 3010667733
- 3013176080
- 3002807295
- 3015207155
- 2133928
- 3035366890
- 3008868758
- 1526350
- 3008021110
- 1834331
- 1220477
- 3013791180
- 3015516266
- 1219655
- 3036756245
- 1226544
- 3011274144
- 3026771806
- 1526534
- 3010178296
- 3008395353
- 3006017180
- 1221934
- 3025603301
- 3017397663
- 3006356043
- 3007740680
- 3033509898
- 1822565
- 1043534
- 3002806603
- 3014207283
- 1649390
- 8031020
- 2134285
Source Documents#
Other 510(k) Records For Product Code JDB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022-10-26 |
| K193247 | LATITUDE EV™ Total Elbow Arthroplasty | Tornier, Inc. | 2020-08-05 |
| K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018-12-27 |
| K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017-08-31 |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | Small Bone Innovations, Inc. | 2010-12-20 |
| K100562 | LATITUDE ELBOW PROSTHESIS | Tornier, Inc. | 2010-06-29 |
| K070787 | LATITUDE ELBOW PROTHESIS | Tornier | 2007-08-24 |
| K070236 | SBI LATERAL RADIO CAPITELLUM | Small Bone Innovations, Inc. | 2007-02-21 |
| K060438 | RHS | Tornier | 2006-04-18 |
| K060038 | SBI RADIO-CAPITELLAR IMPLANT | Small Bone Innovations, Inc. | 2006-03-30 |
| K050848 | TORNIER ELBOW PROSTHESIS | Tornier | 2005-07-14 |
| K031218 | MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2003-05-16 |
| K011567 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2001-06-19 |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Johnson & Johnson Professionals, Inc. | 1998-11-06 |
| K960087 | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) | Wrightmedicaltechnologyinc | 1996-09-20 |
Legacy Summary#
summary
FDA Review#
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