510(k) K992346
- Device
- KINEMATIC II ROTATING HINGE KNEE
- Applicant
- HOWMEDICA OSTEONICS CORP.
- 510(k) number
- K992346
- Product code
- LGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-12
- Date received
- 1999-07-13
- Regulation
- 888.3530
- Classification name
- Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN ARIEMMA
- Address
- 59 Rte. 17 S. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3003387384
- 2249697
- 3010173425
- 3000264985
- 9610726
Source Documents#
Other 510(k) Records For Product Code LGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K811630 | KINEMATIC ROTATING HINGE TOTAL KNEE PR. | Howmedica Corp. | 1981-07-01 |
Legacy Summary#
summary
FDA Review#
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