Data / Medical devices / United States / Exactech Sarasota
Exactech Sarasota: FDA-registered device maker in Sarasota, FL, United States, 33 510(k) clearances
Exactech Sarasota is registered with the FDA (registration 3008658204) in Sarasota, FL, United States. It lists 12 device types. The FDA files 33 510(k) clearances under its listings, the newest dated July 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008658204
- Address
- 7455 16th Street East Suite 105, Sarasota, FL, United States, 34243
- Owner or operator
- EXACTECH, INC. (1038671)
- Roles
- Manufacturer
- First device listed
- July 15, 1992
- Registered through
- 2026
- Brand names listed
- Alteon Bone Screws, BIT, Cemented Total Knee Sys Tibial Comp, Cruciate Retaining Cemented Knee, Cruciate Retaining Cemented Tibial, EXACTECH HIP, Equinoxe, Equinoxe Cage Glenoid and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2024 | K233482 | Equinoxe® Central Screw Baseplate System | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 20, 2019 | K191561 | Exactech Equinoxe Humeral Augmented Trays | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 26, 2018 | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | MBH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 28, 2017 | K171045 | Exactech® Truliant Line Extensions | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 10, 2016 | K152217 | Exactech Vantage Total Ankle System | HSN | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 3, 2015 | K152170 | Exactech Optetrak Logic Enhanced Assembly | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 29, 2015 | K150890 | Exactech Optetrak Logic CC | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 9, 2015 | K143659 | Equinoxe Mega Prosthesis | KWT | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 29, 2014 | K141797 | ALTEON 6.5MM BONE SCREWS | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 11, 2013 | K132161 | OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 10, 2013 | K123342 | OPTETRAK LOGIC CRC TIBIAL INSERT | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| December 6, 2012 | K121067 | EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 31, 2012 | K121307 | OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| December 8, 2011 | K113309 | EXACTECH EQUINOXE CAGE GLENOIDS | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 28, 2011 | K111400 | OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 14, 2011 | K110547 | OPTERTRAK LOGIC PSC TIBIAL INSERT | JWH | Substantially Equivalent | Exactech Sarasota | accessdata.fda.gov |
| April 1, 2011 | K110708 | EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| December 13, 2010 | K103419 | EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 4, 2010 | K102951 | EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 2, 2010 | K093430 | EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 11, 2010 | K093978 | EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM | HRS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 11, 2010 | K093360 | OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 2, 2008 | K082022 | OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 23, 2007 | K063569 | EQUINOXE REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 26, 2004 | K042021 | EXACTECH EQUINOXE SHOULDER SYSTEM | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 1, 2004 | K040889 | EXACTECH OPTETRAK UNICONDYLAR KNEE | HRY | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 13, 2004 | K033883 | OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 17, 2002 | K023186 | OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 16, 2001 | K011976 | OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 26, 1996 | K954208 | OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY | JWH | Substantially Equivalent for Some Indications | Exactech, Inc. | accessdata.fda.gov |
| February 9, 1995 | K932690 | EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY | JWH | Substantially Equivalent for Some Indications | Exactech, Inc. | accessdata.fda.gov |
| January 17, 1995 | K933610 | EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS | JWH | Substantially Equivalent for Some Indications | Exactech, Inc. | accessdata.fda.gov |
| October 20, 1994 | K932776 | CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS | JWH | Substantially Equivalent for Some Indications | Exactech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Bit, Drill
Updated July 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.