Lateral Button
by T.A.G. Medical products corporation LTD.
510(k) K112296
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112296 | Date1 Dec 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MBI
- FDA applicant
- T.A.G. Medical Products Corporation, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lateral Button is an orthopedic fixation device classified under product code MBI (Muscle, Bone, and Soft Tissue Fixation Devices). It is designed as a surgical implant intended for internal fixation of bone fractures, providing stability through mechanical anchoring. Constructed from PEEK (polyether etherketone), a biocompatible material commonly used in orthopedic implants, it is engineered to withstand physiological stresses while promoting bone healing. Its design facilitates secure attachment to bone surfaces, aiding in the restoration of skeletal integrity during orthopedic procedures.
The Lateral Button is supplied as a sterile, single-use device intended for surgical application under aseptic conditions. It is regulated under 21 CFR 888.3040 and holds an FDA 510(k) clearance (K112296) as substantially equivalent to a predicate device, determined through a traditional review process by the Orthopedic (OR) Advisory Committee. No additional sterilization or reprocessing is required post-implantation, as it is intended for permanent internal use. Storage should adhere to manufacturer guidelines to maintain sterility and material integrity prior to surgical use.
From the manufacturer
T.A.G. Medical Products Corporation Ltd Kibbutz Gaaton 2513000 Israel Tel: +972 (0) 4 9858400 Fax: +972 (0) 4 9858404 Email: . Message.
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Questions
AI-generated answers, 1 Oct 2026
What is the Lateral Button used for?
The Lateral Button is designed as an orthopedic fixation device for internal stabilization of bone fractures. Its PEEK construction provides mechanical anchoring to bone surfaces, helping restore skeletal integrity during surgical procedures. The device is specifically classified under product code MBI for muscle, bone, and soft tissue fixation.
Is the Lateral Button reusable or single-use?
The Lateral Button is intended for single-use only. It is supplied sterile and is not meant to be reprocessed or reused after implantation. This ensures patient safety and maintains the device’s structural integrity and biocompatibility.
What material is the Lateral Button made from?
The Lateral Button is constructed from PEEK (polyether etherketone), a biocompatible material widely used in orthopedic implants. PEEK is chosen for its ability to withstand physiological stresses while promoting bone healing and integration.
How should the Lateral Button be stored before use?
The Lateral Button must be stored according to the manufacturer’s guidelines to preserve sterility and material integrity. Since it is a sterile, single-use device, proper storage ensures it remains uncontaminated until surgical application.
Does the Lateral Button require any additional sterilization after implantation?
No, the Lateral Button is intended for permanent internal use and does not require any post-implantation sterilization or reprocessing. It is designed to remain in place as part of the healing process without further handling.