510(k) K811630
- Device
- KINEMATIC ROTATING HINGE TOTAL KNEE PR.
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K811630
- Product code
- LGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-01
- Date received
- 1981-06-09
- Regulation
- 888.3530
- Classification name
- Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3003387384
- 9610726
- 2249697
- 3010173425
- 3000264985
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992346 | KINEMATIC II ROTATING HINGE KNEE | Howmedica Osteonics Corp. | 1999-08-12 |
Legacy Summary#
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FDA Review#
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