510(k) K150428
- Device
- 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.
- 510(k) number
- K150428
- Product code
- HAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-16
- Date received
- 2015-02-19
- Regulation
- 882.4840
- Classification name
- Rongeur, Manual
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Judith E O'Grady
- Address
- 311 Enterprise Dr. Planisboro NJ US 08536 08536
FDA Registration Numbers#
- 3008711893
- 8030607
- 3004608878
- 8010422
- 9611814
- 1220477
- 1417592
- 3009704301
- 3009662229
- 3012995405
- 3008864603
- 8044057
- 3016450051
- 8010877
- 9680515
- 9610612
- 3006554912
- 2951215
- 3005809810
- 8010697
- 8010769
- 9611616
- 3005641619
- 3005977257
- 3011137372
- 1058020
- 1421101
- 1424478
- 8043548
- 3011245468
- 1219659
- 1450662
- 9614945
- 3004215117
- 3012507533
- 3010041511
- 3003418325
- 1057946
- 9710524
- 3014967969
- 3004893332
- 1221541
- 3010687973
- 9615005
- 1836161
- 1923569
- 3015967359
- 9610905
- 8040233
- 3014334038
- 8010386
- 1056350
- 2085947
- 9615004
- 3005528784
- 3007648354
- 2916714
- 2027754
- 9611503
Source Documents#
Other 510(k) Records For Product Code HAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242759 | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | 2025-06-06 |
| K223596 | SQ.line KERRISON | Aesculap, Inc. | 2023-06-29 |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2023-03-03 |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2022-10-07 |
| K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | 2022-06-03 |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2021-05-04 |
| K200383 | Wiggins Medical Surgical Instruments | Wiggins Medical | 2020-07-21 |
| K200387 | Ace Medical Surgical Instruments | Ace Medical | 2020-07-21 |
| K180949 | Steribite | Rjr Surgical, Inc. | 2018-11-08 |
| K161744 | Symmetry Sharp Kerrison Rongeur | Symmetry Surgical, Inc. | 2016-09-07 |
| K153243 | Fehling-Punches | Fehling Instruments GmbH & Co. KG | 2016-08-04 |
| K152734 | Kerrison Rongeurs | Vitalitec Medizintechnik GmbH | 2016-06-18 |
| K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | 2016-02-29 |
| K131851 | OSTEOMED NEURO RONGEUR | Osteomed | 2013-12-06 |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | Symmetry Surgical | 2013-08-05 |
Legacy Summary#
summary
FDA Review#
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