510(k) K103419
- Device
- EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
- Applicant
- EXACTECH, INC.
- 510(k) number
- K103419
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-13
- Date received
- 2010-11-22
- Regulation
- 888.3660
- Classification name
- Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- PATRICK HUGHES
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers
- 3003403260
- 1423662
- 1450662
- 1000200989
- 3027484613
- 1833506
- 1422572
- 3004641308
- 3005180920
- 2133928
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- 3014207283
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- 3008021110
- 1835444
- 3008337808
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- 3009153862
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- 3003998208
- 2528981
- 9616671
- 3010375065
- 1529009
- 3004983210
- 3006984710
- 3014302784
- 3010898856
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| 10885862085580 | Equinoxe | Exactech, Inc. | 2022-08-18 |
| 10885862085573 | Equinoxe | Exactech, Inc. | 2022-08-18 |
| 10885862085566 | Equinoxe | Exactech, Inc. | 2022-08-18 |
| 10885862085559 | Equinoxe | Exactech, Inc. | 2022-08-18 |
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| 10885862085474 | Equinoxe | Exactech, Inc. | 2022-07-28 |
| 10885862085481 | Equinoxe | Exactech, Inc. | 2022-07-28 |
| 10885862085498 | Equinoxe | Exactech, Inc. | 2022-07-28 |
| 10885862085924 | Equinoxe | Exactech, Inc. | 2022-07-28 |
| 10885862243089 | Equinoxe | Exactech, Inc. | 2022-07-28 |
| 10885862243072 | Equinoxe | Exactech, Inc. | 2022-07-28 |
Legacy Summary
summary
FDA Review
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