Data / Medical devices / United States / Pace Surgical
Pace Surgical: FDA-registered device maker in Malvern, PA, United States, 1 510(k) clearance
Pace Surgical is registered with the FDA (registration 3042765769) in Malvern, PA, United States. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042765769
- Address
- 7 Great Valley Pkwy Ste 295, Malvern, PA, United States, 19355
- Owner or operator
- Pace Surgical (10094629)
- Roles
- Specification developer
- First device listed
- December 11, 2025
- Registered through
- 2026
- Brand names listed
- Pace Surgical Instruments, Ultra Compression Screw System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2025 | K251555 | Ultra Compression Screw System | HWC | Substantially Equivalent | Pace Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Surgical, Instrument
- All makers of Washer, Bolt Nut
- All makers of Screw, Fixation, Bone
- All makers of Tap, Bone
- All makers of Bit, Drill
- All makers of Orthopedic Manual Surgical Instrument
Updated November 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.