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Sign in to claim this brandKLS-Martin L.P.
US
Last updated September 17, 2026
What KLS-Martin L.P. makes
KLS-Martin L.P. manufactures reusable surgical instruments, including craniofacial fixation plates and screws (non-bioabsorbable), implantable craniofacial bone distractors, spinal rongeurs, soft-tissue manipulation forceps, and hand-held retractors. Their portfolio also includes orthopaedic bone screws (non-sliding) and general-purpose surgical scissors.
The company’s devices are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does KLS-Martin L.P. manufacture?
KLS-Martin L.P. specializes in reusable surgical instruments and implants, including craniofacial fixation plates and screws (non-bioabsorbable), implantable craniofacial bone distractors, spinal rongeurs, soft-tissue manipulation forceps, retractors, and orthopaedic bone screws (non-sliding). Their product line also covers general-purpose surgical scissors. These devices are designed for use in craniofacial, orthopaedic, and general surgical procedures.
Where is KLS-Martin L.P. based, and what regulatory framework applies to its devices?
KLS-Martin L.P. is based in the United States. Their devices fall under FDA regulation, with most classified as Class I or Class II. This classification determines the level of scrutiny and regulatory requirements, such as pre-market notifications (510(k)) for Class II devices, while Class I devices may have fewer regulatory hurdles but still require compliance with general controls.
Are KLS-Martin L.P.’s devices listed in any regulatory registries, and why does this matter?
Yes, KLS-Martin L.P.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify device details such as manufacturer, model, and batch information. Listing in the UDI database is mandatory for most medical devices in the U.S. to support post-market surveillance and recall management.
How are KLS-Martin L.P.’s craniofacial and orthopaedic devices classified under FDA regulations?
KLS-Martin L.P.’s craniofacial fixation plates, screws, and bone distractors are typically classified as Class II devices under FDA regulations due to their role in structural or functional body modifications. These devices require pre-market submissions (such as 510(k)s) to demonstrate safety and effectiveness, as they pose moderate risks if misused or malfunctioning. In contrast, reusable surgical instruments like retractors or scissors are often Class I, subject to general controls like good manufacturing practices (GMPs) but not requiring pre-market approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 11201 Saint Johns Industrial Pkwy S, Jacksonville, FL, 32246
- Website
- klsmartin.com
- —
- —
- [email protected]
- Phone
- +1(904)641-7746
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000525271
- DUNS Number
- 826499238
Catalogue (13158)
Page 9 of 264| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Level One Small Bone | 26-023-24-09 | FDA UDI | Class II | Unknown |
| Level One Cmf | 25-662-15-09 | FDA UDI | Class II | Active |
| Ips | 60-000-17-09-PP | FDA UDI | Class II | Active |
| Separator | 38-846-20-07 | FDA UDI | Class I | Active |
| Probe | 35-226-78-18 | FDA UDI | Class I | Active |
| Level One Cmf | 25-883-17-61 | FDA UDI | Class II | Active |
| Distraction, Internal, Sterile | 51-410-30-71 | FDA UDI | Class II | Active |
| Osteotome | 37-626-04-07 | FDA UDI | Class I | Active |
| Level One Cmf | 25-556-33-09 | FDA UDI | Class II | Active |
| Level One Neuro | 25-006-53-09 | FDA UDI | Class II | Active |
| Level One Cmf | 01-005-19-09 | FDA UDI | Class II | Unknown |
| Ips | 60-500-07-09 | FDA UDI | Class I | Active |
| Retractor | 15-850-00-07 | FDA UDI | Class I | Active |
| Elevator | 09-301-10-07 | FDA UDI | Class I | Active |
| Periotome | 01-004-80-07 | FDA UDI | Class I | Active |
| Ips | 60-002-85-09-LP | FDA UDI | Class II | Active |
| Distraction, Internal | 99-491-64-02 | FDA UDI | Class II | Active |
| Level One Cmf | 25-774-11-61 | FDA UDI | Class II | Active |
| Distraction, External | 01-001-36-09 | FDA UDI | Class II | Unknown |
| Curette | 00-102-99-07 | FDA UDI | Class I | Active |
| Distraction, Internal, Sterile | 51-401-10-71 | FDA UDI | Class II | Unknown |
| Level One | 25-472-86-07 | FDA UDI | Class I | Unknown |
| Needle Holder | 20-018-15-09 | FDA UDI | Class I | Active |
| Osteotome | 03-401-06-07 | FDA UDI | Class I | Active |
| Ips | 60-000-17-09-LP | FDA UDI | Class II | Active |
| Needle Holder | 20-631-01-07 | FDA UDI | Class I | Active |
| Forceps | 12-120-11-07 | FDA UDI | Class I | Active |
| Spacer | 38-684-18-07 | FDA UDI | Class I | Active |
| Retractor | 15-401-02-07 | FDA UDI | Class I | Unknown |
| Level One | 50-997-07-07 | FDA UDI | Class I | Active |
| Level One Cmf | 25-765-13-91 | FDA UDI | Class II | Active |
| Level One Cmf | 01-005-23-09 | FDA UDI | Class II | Unknown |
| Resorb X, Sterile | 52-306-13-04 | FDA UDI | Class II | Active |
| Level One Cmf | 50-710-04-09 | FDA UDI | Class II | Active |
| Distraction, Internal | 51-412-53-05 | FDA UDI | Class II | Active |
| Level One Neuro | 25-015-09-09 | FDA UDI | Class II | Active |
| Ips | 60-001-62-09 | FDA UDI | Class II | Active |
| Distraction, Internal, Sterile | 51-425-20-71 | FDA UDI | Class II | Active |
| Level One Cmf | 99-587-96-07 | FDA UDI | Class II | Unknown |
| Forceps | 22-500-02-07 | FDA UDI | Class I | Active |
| Needle Holder | 20-642-16-85 | FDA UDI | Class I | Active |
| Clamp | 13-145-35-09 | FDA UDI | Class I | Active |
| Level One | 01-964-12-04 | FDA UDI | Class I | Active |
| Retractor | 04-000-23-07 | FDA UDI | Class I | Active |
| Level One Cmf, Sterile | 25-873-19-71 | FDA UDI | Class II | Active |
| Distraction, Internal, Sterile | 51-557-20-81 | FDA UDI | Class I | Active |
| Scissors | 48-354-16-07 | FDA UDI | Class I | Active |
| Osteotome | 23-138-30-07 | FDA UDI | Class I | Active |
| Level One | 99-962-42-04 | FDA UDI | Class I | Active |
| Dissector | 24-844-26-07 | FDA UDI | Class I | Active |
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