510(k) K960659
- Device
- CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
- Applicant
- WRIGHT MEDICAL TECHNOLOGY, INC.
- 510(k) number
- K960659
- Product code
- KYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-06
- Date received
- 1996-02-16
- Regulation
- 888.3770
- Classification name
- Prosthesis, Wrist, Carpal Trapezium
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CLIFF R KLINE, II
- Address
- 5677 Airline Rd. Arlington TN US 38002 38002
FDA Registration Numbers#
- 3006742481
- 1649379
- 3010178296
- 2244478
- 2090040
- 3009826895
- 3006783837
- 3018282363
- 3003477135
- 3000931034
- 3010667733
- 3002807295
- 1649390
- 3004983210
- 2183946
- 1226544
- 1649833
- 3007993775
- 3003902387
- 1833506
- 1043534
- 3009513193
- 3014207283
Source Documents#
Other 510(k) Records For Product Code KYI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, LLC | 2020-12-02 |
| K180744 | Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, LLC | 2018-04-11 |
| K111068 | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 | Skeletal Dynamics, LLC | 2011-12-30 |
| K112278 | ASCENSION NUGRIP CMC IMPLANT | Ascension Orthopedic | 2011-11-04 |
| K092548 | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | Extremity Medical, LLC | 2009-12-15 |
| K061956 | ARTELON STT SPACER | Artimplant AB | 2007-06-07 |
| K061954 | ARTELON CMC SPACER ARTHRO | Artimplant AB | 2007-06-01 |
| K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | 2006-08-11 |
| K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | Biopro, Inc. | 2006-06-20 |
| K060386 | NEXA CARPO METACARPAL IMPLANT | Nexa Orthopedics, Inc. | 2006-05-10 |
| K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 | Biopro, Inc. | 2005-11-15 |
| K042690 | ASCENSION PYROSPHERE (PCS) | Ascension Orthopedics, Inc. | 2004-11-13 |
| K040070 | ARTELON SPACER CMC-1 | Artimplant AB | 2004-09-21 |
| K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 | Ascension Orthopedics, Inc. | 2004-08-25 |
| K033529 | TIE-IN TRAPEZIUM | Wrightmedicaltechnologyinc | 2003-12-03 |
Legacy Summary#
summary
FDA Review#
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