Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
FDA 510(k) clearance K150428 · decided 2015-04-16
Clearance details
- K-number
- K150428
- Device name
- Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-19
- Decision date
- 2015-04-16
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- HAE
- Device class
- 2
- Regulation number
- 882.4840
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Ace Medical Surgical Instruments (K200387) | Ace Medical | 2020-07-21 |
| Wiggins Medical Surgical Instruments (K200383) | Wiggins Medical | 2020-07-21 |
| Steribite (K180949) | Rjr Surgical, Inc. | 2018-11-08 |
| Symmetry Sharp Kerrison Rongeur (K161744) | Symmetry Surgical, Inc. | 2016-09-07 |
| Fehling-Punches (K153243) | Fehling Instruments GmbH & Co. KG | 2016-08-04 |
| Kerrison Rongeurs (K152734) | Vitalitec Medizintechnik GmbH | 2016-06-18 |
Recalls involving this device
No recalls on record reference this clearance.