510(k) K964500
- Device
- ACUMED TENSION BAND PIN
- Applicant
- ACUMED, INC.
- 510(k) number
- K964500
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-12-09
- Date received
- 1996-11-08
- 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
- SHARI L JEFFERS
- Address
- 10950 SW 5th St. Suite 170 Beaverton OR US 97005 97005
FDA Registration Numbers#
- 3012103978
- 3002579136
- 3016851379
- 3015806723
- 3015895045
- 3019269298
- 3015974593
- 2183785
- 1221053
- 3013700547
- 3009381600
- 3012358417
- 1828288
- 3009110133
- 1220477
- 3006783837
- 3035366890
- 3000270450
- 3008793310
- 3006498370
- 3013055499
- 1835572
- 3020745223
- 2032098
- 1018470
- 3011302692
- 1833986
- 3021393544
- 3008812251
- 3005827567
- 3014262693
- 3010162973
- 1825034
- 3016727307
- 3027242374
- 1836357
- 3002807295
- 3007366790
- 2249529
- 3009971621
- 9615765
- 1048735
- 3011580264
- 3006801265
- 3014129047
- 3040335671
- 3004638532
- 3021008900
- 3012966183
- 3003418325
- 3014314623
- 1221934
- 3008102042
- 8043862
- 3021226419
- 3007539489
- 3014554088
- 3006524618
- 3020899789
- 1226191
- 3009631939
- 3011301313
- 3005061536
- 3019455
- 3009141957
- 3016496998
- 3007130914
- 3011127597
- 1421101
- 1124621
- 1423662
- 3011656326
- 3009826895
- 1043534
- 3010673777
- 1720929
- 3003236702
- 3027553380
- 1043653
- 1054811
Source Documents#
Other 510(k) Records For Product Code HTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022-02-17 |
| K211789 | restor3d Pin Implants | Restor3D | 2022-01-04 |
Legacy Summary#
summary
FDA Review#
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