Panels › Orthopedic › Product code HWX · Class 1
Tap, Bone
Regulation 888.4540
0510(k)s in 12 months (2 all time)
2recalls in 12 months (15 all time)
4recalls that name a 510(k)
Top companies in HWX
| Company | 510(k)s | Recalls |
|---|---|---|
| Blackstone Medical, Inc. | 0 | 5 |
| Orthohelix Surgical Designs Inc | 0 | 3 |
| Synthes (USA) Products LLC | 0 | 2 |
| Amtech Scientific, Inc. | 1 | 0 |
| Buckman Co., Inc. | 1 | 0 |
| Smith & Nephew Inc | 0 | 1 |
| Sterilmed Inc | 0 | 1 |
| Surgical Instrument Service And Savings, Inc. | 0 | 1 |
| Zimmer GmbH | 0 | 1 |
| Zimmer Spine, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2026 | Synthes (USA) Products LLC 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. Open, Classified |
HWX | None listed |
| Mar 30, 2026 | Synthes (USA) Products LLC 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. Open, Classified |
HWX | None listed |
| Apr 8, 2019 | Zimmer GmbH CBS 7.5 tap, cannulated, AO, Item Number 503002041 Terminated |
HWX | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447.
Orthopedic manual surgical instrument Terminated |
HWX | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
HWX | None listed |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 Terminated |
HWX | K060428 |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021 Terminated |
HWX | K060428 |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031 Terminated |
HWX | K060428 |
| May 19, 2010 | Blackstone Medical, Inc. 8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| Jan 13, 2009 | Sterilmed Inc Taps
Model #'s:
SYN311.15
SYN311.190
SYN311.39 and
SYN311.32
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use w Terminated |
HWX | None listed |
| Feb 24, 2005 | Zimmer Spine, Inc. Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Terminated |
HWX | K022344 |
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