KineMatch® PFR System 22-800-2002

GUDID 00818720010885

TROCHLEA DRILL GUIDE STABILIZATION PIN

Kinamed, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00818720010885
• NIH Device Record Key: b087f3ce-2454-4a52-9f1e-5da116b5443e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KineMatch® PFR System
• Version Model Number: 22-800-2002
• Catalog Number: 22-800-2002
• Company DUNS: 184896645
• Company Name: Kinamed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818720010885 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

[00818720010885]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [KineMatch® PFR System]

• 00818720011257: Custom PFR Primary Right
• 00818720011240: Custom PFR Primary Left
• 00818720010854: PFR Right
• 00818720010847: PFR Left
• 00818720010830: Onlay Dome Patella Implant Tri-Peg Size 4 (39 x 11mm)
• 00818720010823: Onlay Dome Patella Implant Tri-Peg Size 3 (36 x 10mm)
• 00818720010816: Onlay Dome Patella Implant Tri-Peg Size 2 (33 x 9mm)
• 00818720010809: Onlay Dome Patella Implant Tri-Peg Size 1 (30 x 8mm)
• 00818720013138: Autoclave Case, Lid
• 00818720013121: Autoclave Case, Nipple Mat
• 00818720013114: Autoclave Case, Base
• 00818720011165: PATELLA TRIAL, 39mm
• 00818720011158: PATELLA TRIAL, 36mm
• 00818720011141: PATELLA TRIAL, 33MM
• 00818720011134: PATELLA TRIAL, 30MM
• 00818720011127: PATELLA CALIPER, PINCH
• 00818720011110: PATELLA CUSHION FOR PARALLEL ACTION CLAMP
• 00818720011103: PATELLA CUSHION COLLAR FOR PARALLEL ACTION CLAMP
• 00818720011097: PATELLA SIZING RING, 39mm
• 00818720011080: PATELLA SIZING RING, 36mm
• 00818720011073: PATELLA SIZING RING, 33mm
• 00818720011066: PATELLA DRILL GUIDE FOR PARALLEL ACTION CLAMP
• 00818720011059: PATELLA PARALLEL ACTION CLAMP
• 00818720011042: PATELLA RESECTION GUIDE
• 00818720011035: PATELLA SIZER AND DRILL GUIDE, 36/39mm
• 00818720011028: PATELLA SIZER AND DRILL GUIDE, 30/33mm
• 00818720011004: PATELLA CLAMP
• 00818720010991: PATELLA STOP DRILL, 6mm
• 00818720010984: PATELLA RESECTION GUIDE
• 00818720010977: TROCHLEA RING CURETTE, 12mm
• 00818720010960: TROCHLEA NAIL EXTRACTOR
• 00818720010953: TROCHLEA RING CURETTE, 8mm
• 00818720010946: TROCHLEA PIN PULLER
• 00818720010939: TROCHLEA DRILL GUIDE FIXATION NAIL
• 00818720010922: TROCHLEA FIXATION NAIL PILOT DRILL
• 00818720010892: TROCHLEA IMPACTOR
• 00818720010885: TROCHLEA DRILL GUIDE STABILIZATION PIN
• 00818720010878: TROCHLEA STOP DRILL, 8mm
• 00818720010861: INSTRUMENT TRAY (AUTOCLAVE CASE)
• 00818720011318: CUSTOM PFR TRIAL IMPLANT RIGHT
• 00818720011301: CUSTOM PFR TRIAL IMPLANT LEFT
• 00818720011271: CUSTOM PFR DRILL GUIDE RIGHT
• 00818720011264: CUSTOM PFR DRILL GUIDE LEFT
• 00818720011011: PATELLA CALIPER, SLIDING
• 00818720010915: DRILL GUIDE RIGHT
• 00818720010908: DRILL GUIDE LEFT
• 00818720011295: CUSTOM PFR AUTOCLAVABLE BONE MODEL LEFT
• 00818720011288: CUSTOM PFR AUTOCLAVABLE BONE MODEL RIGHT