510(k) K003269
- Device
- UNICONDYLAR INTERPOSITIONAL SPACER
- Applicant
- SULZER ORTHOPEDICS, INC.
- 510(k) number
- K003269
- Product code
- HSH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-01-04
- Date received
- 2000-10-18
- Regulation
- 888.3590
- Classification name
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MITCHELL A DHORITY
- Address
- 9900 Spectrum Dr. Austin TX US 78717 78717
FDA Registration Numbers#
- 1526534
- 1822565
- 1450662
- 1825034
Source Documents#
Other 510(k) Records For Product Code HSH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073233 | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | Advanced Bio-Surfaces, Inc. | 2008-01-28 |
| K053094 | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 | Advanced Bio-Surfaces, Inc. | 2006-02-06 |
| K033242 | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | Imaging Therapeutics, Inc. | 2003-12-31 |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | Osteoimplant Technology, Inc. | 2002-11-20 |
Legacy Summary#
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FDA Review#
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