Smooth or Threaded Metallic Bone Fastener
FDA 510(k) K131640 · Biomedical Ent., Inc.
510(k) numberK131640
Submission
- Device name
- Smooth or Threaded Metallic Bone Fastener
- Applicant
- Biomedical Ent., Inc.
San Antonio, TX, US - Received
- June 4, 2013
- Decision date
- October 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from OSSIO , Ltd.
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| K102107 | Osstaple ChillJDR · Special | 09/03/2010SE |
| K091951 | HammerlockHTY · Traditional | 02/19/2010SE |
| K023203 | OsstapleJDR · Special | 10/17/2002SE |
| K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the…JDR · Traditional | 03/13/2001SE |
| K001353 | Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for…HBW · Traditional | 03/13/2001SE |
| K001219 | Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple SystemJEY · Traditional | 06/21/2000SE |
| K993714 | Memograph Staple, Warm SystemJDR · Traditional | 02/25/2000SE |
| K971782 | Bone and Marrow Collection System KitGEY · Traditional | 07/29/1997SE |
Questions and answers
When was Smooth or Threaded Metallic Bone Fastener cleared by the FDA?
Smooth or Threaded Metallic Bone Fastener (K131640) received a 510(k) decision of Substantially Equivalent on October 16, 2013, 134 days after the submission was received.
What is the product code of K131640?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.