Intermedics Orthopedics Reamers
FDA 510(k) K931733 · Intermedics Orthopedics
510(k) numberK931733
Submission
- Device name
- Intermedics Orthopedics Reamers
- Applicant
- Intermedics Orthopedics
Austin, TX, US - Received
- April 7, 1993
- Decision date
- January 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTP – File
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870842 | Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional | Warsaw Orthopedic, Inc. | 05/27/1987SE |
| K862659 | Concept Arthroscopy RaspHTP · Traditional | Concept, Inc. | 09/02/1986SE |
| K841981 | 4MM & 5MM FileHTP · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K840492 | Sun-Lite Blue SlitHTP · Traditional | Suncoast Medical Manufacturers, Inc. | 05/09/1984SE |
More from Suncoast Medical Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970300 | Natural-Hip System Porous Stem with Ha/CstiLPH · Traditional | 07/03/1997SE |
| K970498 | Natural-Knee II Revision Femoral Spacer LugsJWH · Traditional | 04/30/1997SE |
| K970166 | Natural-Hip System Cocr Revision StemLZO · Traditional | 04/08/1997SE |
| K970567 | Select Shoulder Curved-Back Pegged All Poly GlenoidsKWT · Traditional | 02/27/1997SE |
| K964357 | Natural-Hip System Cocr StemLZO · Traditional | 01/27/1997SE |
| K964350 | Modula Options for Severe Bone Loss and TraumaJDI · Traditional | 01/16/1997SE |
| K962190 | Patellofemoral Joint ProsthesisKRR · Traditional | 10/28/1996SE |
| K963266 | Natural Hip System Porous Stem - Collarless, CollaredLPH · Traditional | 10/15/1996SE |
| K963155 | Intermoore Fracture Hip Stem (Modify)LWJ · Traditional | 10/01/1996SE |
| K962315 | Select Shoulder Cocr Humeral Stem ComponentKWT · Traditional | 09/03/1996SE |
Questions and answers
When was Intermedics Orthopedics Reamers cleared by the FDA?
Intermedics Orthopedics Reamers (K931733) received a 510(k) decision of Substantially Equivalent on January 26, 1994, 294 days after the submission was received.
What is the product code of K931733?
The FDA product code is HTP – File, a Class I (low risk) device regulated under 21 CFR 888.4540.