510(k) K010081
- Device
- ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
- Applicant
- EXACTECH, INC.
- 510(k) number
- K010081
- Product code
- KWY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-02-05
- Date received
- 2001-01-10
- Regulation
- 888.3390
- Classification name
- Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Simpson
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 1000550978
- 3003061090
- 9616680
- 1000577893
- 3006128100
- 8010379
- 3007200272
- 2528981
- 3022142628
- 9610612
- 3014763043
- 2244478
- 3021008900
- 3013194153
- 3007740680
- 3002807314
- 1226188
- 3010537287
- 3016851379
- 3010287737
- 3005323511
- 3033509898
- 3016438761
- 3008110533
- 3013186738
- 3009760038
- 3005562917
- 2648920
- 1047843
- 3015398319
- 3002907620
- 3010206549
- 2032521
- 3000196378
- 3026771806
- 3009973505
- 1043653
- 3004371426
- 1221053
- 2249697
- 3021566676
- 3008868758
- 1644408
- 3006395932
- 2245304
- 3010097171
- 1018470
- 3008262872
- 3009756327
- 3010363503
- 3008556682
- 9617083
- 9616671
- 8043792
- 1057425
- 1818910
- 1000547811
- 1836357
- 3009475821
- 3005913274
- 3020282716
- 1220477
- 3010220595
- 3005061536
- 3009888740
- 3005333358
- 3006001176
- 3010041693
- 3003998208
- 3008021110
- 9616944
- 3005180920
- 3005551626
- 1020279
- 1825034
- 3002806470
- 1226544
- 3001278222
- 1643817
Source Documents#
Other 510(k) Records For Product Code KWY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | 2026-04-13 |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | 2025-08-25 |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | 2023-12-19 |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | 2023-03-23 |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | 2022-07-20 |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | 2022-03-23 |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | 2020-04-17 |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | 2019-11-05 |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | 2019-11-01 |
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019-09-17 |
| K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | 2019-08-28 |
| K183114 | Corin BiPolar-i | Corin U.S.A. Limited | 2019-06-05 |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018-06-14 |
| K180130 | ELEOS™ Bipolar Acetabular System | Onkos Surgical, Inc. | 2018-02-23 |
| K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | 2018-01-29 |
Legacy Summary#
summary
FDA Review#
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