TMP Microplating System
FDA 510(k) K921458 · Techmedica, Inc.
510(k) numberK921458
Submission
- Device name
- TMP Microplating System
- Applicant
- Techmedica, Inc.
Camarillo, CA, US - Received
- March 27, 1992
- Decision date
- July 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K933935 | CKS Porous Coated Femoral ComponentHRY · Traditional | 10/11/1994SE |
| K932017 | Techmedica Continuum Hip with Ha CoatingMEH · Traditional | 09/01/1994SE |
| K931929 | Techmedica Continuum Hip SystemLZO · Traditional | 03/29/1994SE |
| K926387 | Techmedica Standard Cemented Hip SystemKWY · Traditional | 02/01/1994SE |
| K925420 | Techmedica Standard Bipolar SystemKWY · Traditional | 09/28/1993SE |
| K923808 | Muller Straight Stem Femoral ProsthesisLZO · Traditional | 07/27/1993SE |
| K926579 | Techmedica 6.5MM Self-Tapping Cancellous Bone ScreHWC · Traditional | 04/06/1993SE |
| K911058 | Techmedica Cad/Cam Custom HipJDI · Traditional | 02/23/1993SE |
| K925181 | Techmedica Mueller Type Polyethylene Acetbul CupJDL · Traditional | 02/05/1993SE |
| K920080 | Continuum Knee SystemJWH · Traditional | 09/01/1992SN |
Questions and answers
When was TMP Microplating System cleared by the FDA?
TMP Microplating System (K921458) received a 510(k) decision of Substantially Equivalent on July 17, 1992, 112 days after the submission was received.
What is the product code of K921458?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.