Hammerlock 2
FDA 510(k) K133520 · Biomedical Enterprises, Inc.
510(k) numberK133520
Submission
- Device name
- Hammerlock 2
- Applicant
- Biomedical Enterprises, Inc.
San Antonio, TX, US - Received
- November 15, 2013
- Decision date
- January 9, 2014
- 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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| K153573 | ConvergeHRS · Traditional | 08/11/2016SE |
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| K143023 | Nitinol Compression Plating SystemHRS · Traditional | 01/16/2015SE |
| K142292 | Speed, Speed Shift, Speed Titan, Speed ArcJDR · Traditional | 11/17/2014SE |
| K133270 | Speed ArcJDR · Traditional | 04/17/2014SE |
| K124022 | Speed ShiftJDR · Traditional | 05/14/2013SE |
| K061385 | Osstaple, Ossplate, OssforceKWQ · Traditional | 05/30/2007SE |
| K023488 | Osstaple, CraniofacialJEY · Special | 10/31/2002SE |
| K023486 | Osstaple, MaxillofacialJEY · Special | 10/31/2002SE |
Questions and answers
When was Hammerlock 2 cleared by the FDA?
Hammerlock 2 (K133520) received a 510(k) decision of Substantially Equivalent on January 9, 2014, 55 days after the submission was received.
What is the product code of K133520?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.