510(k) K024022
- Device
- OSTEO-CABLE SLEEVE
- Applicant
- BIOMET, INC.
- 510(k) number
- K024022
- Product code
- HXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-23
- Date received
- 2002-12-05
- Regulation
- 888.4540
- Classification name
- Applier, Cerclage
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KACY ARNOLD
- Address
- 56 E Bell Dr. Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3010531060
- 9680411
- 9616250
- 3005440795
- 3005067367
- 1825034
- 3010667733
- 3013176080
- 8040278
- 3012130008
- 3016443334
- 3015207155
- 3013846070
- 8010298
- 3035708926
- 3035366890
- 9611283
- 1833824
- 9680518
- 3008711893
- 3010536692
- 1822565
- 3003244954
- 1043534
- 9610612
- 9613910
Source Documents#
Other 510(k) Records For Product Code HXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K841628 | WIRE | Plastafil, Inc. | 1984-07-23 |
Legacy Summary#
summary
FDA Review#
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