510(k) K022779
- Device
- OTI UNICONDULAR INTERPOSITIONAL SPACER
- Applicant
- OSTEOIMPLANT TECHNOLOGY, INC.
- 510(k) number
- K022779
- Product code
- HSH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-20
- Date received
- 2002-08-22
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAM SON
- Address
- 11201 Pepper Rd. Hunt Valley MD US 21031 21031
FDA Registration Numbers#
- 1526534
- 1825034
- 1450662
- 1822565
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K003269 | UNICONDYLAR INTERPOSITIONAL SPACER | Sulzer Orthopedics, Inc. | 2001-01-04 |
Legacy Summary#
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FDA Review#
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