510(k) K203421
- Device
- Triathlon AS-1
- Applicant
- Conformis Inc.
- 510(k) number
- K203421
- Product code
- OOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-19
- Date received
- 2020-11-20
- Regulation
- 888.3560
- Classification name
- Knee Arthroplasty Implantation System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mary Kruitwagen
- Address
- 600 Technology Park Dr., 4th Floor Billerica MA US 01821 01821
FDA Registration Numbers#
- 3007366790
- 3010375065
- 2245304
- 1724955
- 1818910
- 9617840
- 1450662
- 3011724582
- 3038503932
- 3005718816
- 1825034
- 3009293341
- 3006801265
- 3004153240
- 3021008900
- 3012130008
- 3002907620
- 3009555440
- 1223434
- 1020279
- 3019006180
- 3008868758
- 3009555447
- 3004358587
- 2246552
- 1219655
- 3006694268
- 3009106092
- 9680215
- 3003998208
- 3010536692
- 1822565
- 3030409224
- 3005874553
- 3014833750
- 1828464
- 3005061536
- 3010856250
- 3008744062
Source Documents#
Other 510(k) Records For Product Code OOG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | 2023-12-20 |
Legacy Summary#
summary
FDA Review#
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