510(k) K961522
- Device
- KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
- Applicant
- SYNVASIVE TECHNOLOGY, INC.
- 510(k) number
- K961522
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-23
- Date received
- 1996-04-22
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL G FISHER
- Address
- 4925 Robert J Mathews Pkwy. El Dorado CA US 95762 95762
FDA Registration Numbers#
- 3025266
- 3009746186
- 9617297
- 3012818475
- 3008868758
- 1822565
- 3011580264
- 3002579136
- 8043792
- 3013011598
- 3014302784
- 3014833750
- 3021008900
- 3011656326
- 1720747
- 1835572
- 1226544
- 3007366790
- 3008749819
- 3022472578
- 3006801265
- 3025141
- 3005180920
- 3009381600
- 2244478
- 3015212339
- 3007993775
- 3007125392
- 3013302242
- 3016727307
- 3006742481
- 2530154
- 3009826895
- 3014527928
- 3010155648
- 3008114965
- 3003477135
- 3015151147
- 3015806723
- 3005641619
- 3011137372
- 1222773
- 3009554293
- 3033509898
- 3008812560
- 3006017180
- 3012329552
- 2936485
- 3002807310
- 3039103971
- 3010400367
- 3005536892
- 3010470577
- 3021226419
- 3010667733
- 3015131017
- 1320894
- 3021336182
- 2031009
- 3011230048
- 3006694268
- 3005827567
- 1833986
- 3010462278
- 3009732568
- 1835831
- 2648666
- 3012770122
- 2031093
- 3002806470
- 8043862
- 3036756245
- 3009540749
- 3013700547
- 3034676720
- 1017294
- 3008817603
- 3011302058
- 3013365802
- 1018470
Source Documents#
Other 510(k) Records For Product Code HTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262126 | Cerclage Wires;K-wires;Steinmann Pins | MK Medical GmbH | 2026-10-22 |
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026-08-28 |
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | 2025-08-01 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | 2023-12-01 |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023-09-14 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 |
Legacy Summary#
summary
FDA Review#
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