Bone Suture Fixation Device
FDA 510(k) K880264 · Orthopedic Systems, Inc.
510(k) numberK880264
Submission
- Device name
- Bone Suture Fixation Device
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- January 22, 1988
- Decision date
- March 23, 1988
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXY – Brace, Drill
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923776 | Benderev Drill GuideHXY · Traditional | Neimark Labs, Inc. | 11/06/1992SE |
| K892904 | Mitek Drill GuideHXY · Traditional | Mitek Surgical Products, Inc. | 09/28/1989SE |
| K880381 | Telos Distal Targeting DeviceHXY · Traditional | Austin Assoc. | 03/15/1988SE |
| K880046 | Hasting Finger Fixator InstrumentsHXY · Traditional | Buckman Co., Inc. | 02/16/1988SE |
| K831043 | Andrews Remote Chuck DrillHXY · Traditional | Orthopedic Systems, Inc. | 04/28/1983SE |
| K770204 | Cement Extractor DrillHXY · Traditional | Depuy, Inc. | 02/08/1977SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Bone Suture Fixation Device cleared by the FDA?
Bone Suture Fixation Device (K880264) received a 510(k) decision of Substantially Equivalent for Some Indications on March 23, 1988, 61 days after the submission was received.
What is the product code of K880264?
The FDA product code is HXY – Brace, Drill, a Class I (low risk) device regulated under 21 CFR 888.4540.